Lower risk Medical device recall · FDA · Published April 7, 2020

Inpeco FlexLab c8000/c16000 Interface Module Recall: Cross Contamination Risk

Inpeco recalls specific FlexLab interface modules that may cause sample cross contamination if the carousel lid stays open or manual processing takes too long. Affected units include part numbers FLX-208-00 and FLX-208-10 with serial numbers listed.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2003-2020Medical device Inpeco ›

Lower-risk recall

When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.

Take action

Contact the company

Recalling firmInpeco S.A.Via San Gottardo 10 · Lugano, Switzerland

✎ GovInfoNow plain-language explainer

Inpeco is recalling certain FlexLab interface modules that could cause cross contamination of samples if the carousel lid remains open or manual processing takes too long. This affects laboratory equipment used for sample handling in medical testing facilities. Read more at govinfonow.com/recall/65469-inpeco-flexlab-c8000-c16000-interface-module-recall-cross-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/65469-inpeco-flexlab-c8000-c16000-interface-module-recall-cross-contamination-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2003-2020

Cite this page

“Inpeco FlexLab c8000/c16000 Interface Module Recall: Cross Contamination Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65469-inpeco-flexlab-c8000-c16000-interface-module-recall-cross-contamination-risk. Based on FDA recall #Z-2003-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2003-2020%22&limit=1).

The FDA announced on April 7, 2020, that Inpeco S.A. is recalling Inpeco FlexLab and ARCHITECT cSystem Interface Modules due to potential sample cross-contamination. The agency issued recall number Z-2003-2020 for the Class II device.

How to tell if you have it

Brand: Inpeco
Products: Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module
Part Numbers: FLX-208-00, FLX-208-10
Serial Numbers: AML.001, FLX.0104, FLX.0105, FLX.0106, FLX.0107, FLX.0108, FLX.0112, FLX.0114, FLX.0115, FLX.0116, FLX.0118, FLX.0119, FLX.0120, FLX.0124, FLX.0125, FLX.0126, FLX.0131, FLX.0133, FLX.0134, FLX.0135, FLX.0136, FLX.0140, FLX.0141, FLX.0142, FLX.0143, FLX.015, FLX.0152, FLX.0155, FLX.0158, FLX.0161, FLX.0163, FLX.0164, FLX.017, FLX.0175, FLX.0178, FLX.018, FLX.0184, FLX.0189, FLX.019, FLX.0196, FLX.020, FLX.021, FLX.023, FLX.026, FLX.027, FLX.030, FLX.032, FLX.033, FLX.038, FLX.040, FLX.044, FLX.045, FLX.047, FLX.051, FLX.052, FLX.053, FLX.054, FLX.055, FLX.058, FLX.059, FLX.063, FLX.064, FLX.065, FLX.066, FLX.067, FLX.068, FLX.071, FLX.072, FLX.074, FLX.075, FLX.076, FLX.077, FLX.079, FLX.080, FLX.081, FLX.091, FLX.092, FLX.095, FLX.099, FLX.101, FLX.102, FLX.103
Units affected: 82

The hazard

According to the FDA, when the analyzer sample carousel lid remains open or a manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.

Context

GovInfoNow's records show Inpeco S.A. has 13 other recalls on record since 2025-10-30. Other recent recalls of similar products include Medline Convenience Kits Recall (2026-07-10), Equinoxe Core Instrument Kit Recall (2026-02-03), and Beckman Coulter CellMek SPS Sample Prep System Software Error Risk (2025-12-23).

How to tell if you have this one

Check for part numbers FLX-208-00 or FLX-208-10 on the interface module. Affected units have serial numbers listed in the recall notice including AML.001 and FLX.0104 through FLX.103.

Brand
Inpeco
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide including in the states of Texas, West Virginia, South Carolina, Delaware, Louisiana, Illinois, Georgia, Florida, New York, Virginia, Arkansas, Wisconsin, California, Minnesota, Missouri, North Carolina, Utah, Michigan, Ohio, Alabama, Oklahoma, Tennessee, Kansas, Hawaii, Arizona, Washington

Recall number	Product, codes & lots	Quantity
Z-2003-2020	Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.; Serial Numbers: AML.001, FLX.0104, FLX.0105, FLX.0106, FLX.0107, FLX.0108, FLX.0112, FLX.0114, FLX.0115, FLX.0116, FLX.0118, FLX.0119, FLX.0120, FLX.0124, FLX.0125, FLX.0126, FLX.0131, FLX.0133, FLX.0134, FLX.0135, FLX.0136, FLX.0140, FLX.0141, FLX.0142, FLX.0143, FLX.015, FLX.0152, FLX.0155, FLX.0158, FLX.0161, FLX.0163, FLX.0164, FLX.017, FLX.0175, FLX.0178, FLX.018, FLX.0184, FLX.0189, FLX.019, FLX.0196, FLX.020, FLX.021, FLX.023, FLX.026, FLX.027, FLX.030, FLX.032, FLX.033, FLX.038, FLX.040, FLX.044, FLX.045, FLX.047, FLX.051, FLX.052, FLX.053, FLX.054, FLX.055, FLX.058, FLX.059, FLX.063, FLX.064, FLX.065, FLX.066, FLX.067, FLX.068, FLX.071, FLX.072, FLX.074, FLX.075, FLX.076, FLX.077, FLX.079, FLX.080, FLX.081, FLX.091, FLX.092, FLX.095, FLX.099, FLX.101, FLX.102, FLX.103	82
Z-2004-2020	Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.; Serial Numbers: ACP.001, ACP.002, ACP.003, ACP.004, ACP.007, ACP.008, ACP.010, ACP.011, ACP.013, ACP.014, ACP.015, ACP.016, ACP.017, ACP.018, ACP.019, ACP.020, ACP.022, ACP.023, ACP.024, ACP.025, ACP.026, ACP.027, ACP.028, ACP.029, ACP.030, ACP.031, ACP.032, ACP.033, ACP.034, ACP.035, ACP.036, ACP.038, ACP.041, ACP.042, ACP.043, ACP.044, ACP.045, ACP.046, ACP.047, ACP.048, ACP.049, ACP.050, ACP.051, ACP.052, ACP.053, ACP.055, ACP.056, ACP.057, ACP.058, ACP.059, ACP.060, ACP.061, ACP.063, ACP.064, ACP.066, ACP.067, ACP.068, ACP.069, ACP.070, ACP.071, ACP.072, ACP.073, ACP.074, ACP.075, ACP.076, ACP.078, ACP.079, ACP.080, ACP.081, ACP.082, ACP.084, ACP.085, ACP.086, ACP.088, ACP.090, ACP.092, ACP.093, ACP.094, ACP.096, ACP.098, ACP.099, ACP.100, ACP.101, ACP.102, ACP.103, ACP.104, ACP.105, ACP.106, ACP.109, ACP.110, ACP.111, ACP.113, ACP.114, ACP.115, ACP.116, ACP.117, ACP.118, ACP.119, ACP.120, ACP.121, ACP.122, ACP.123, ACP.124, ACP.125, ACP.127, ACP.128, ACP.129, ACP.130, ACP.131, ACP.132, ACP.133, ACP.134, ACP.135, ACP.137, ACP.138, ACP.139, ACP.140, ACP.141, ACP.142, ACP.143, ACP.145, ACP.146, ACP.147, ACP.148, ACP.149, ACP.151, ACP.152, ACP.154, ACP.155, ACP.156, ACP.157, ACP.158, ACP.159, ACP.160, ACP.161, ACP.162, ACP.163, ACP.164, ACP.165, ACP.166, ACP.167, ACP.168, ACP.169, ACP.170, ACP.171, ACP.172, ACP.173, ACP.174, ACP.175, ACP.176, ACP.177, ACP.178, ACP.181, ACP.182, ACP.190, ACP.191, ACP.193, ACP.195, ACP.196, ACP.197, ACP.198, ACP.199, ACP.200, ACP.201, ACP.203, ACP.204, ACP.205, ACP.206, ACP.207, ACP.209, ACP.210, ACP.211, ACP.212, ACP.213, ACP.215, ACP.216, ACP.217, ACP.218, ACP.219, ACP.220, ACP.221, ACP.222, ACP.223, ACP.224, ACP.225, ACP.227, ACP.228, ACP.229, ACP.231, ACP.232, ACP.234, ACP.236, ACP.237, ACP.239, ACP.240, ACP.241, ACP.242, ACP.243, ACP.244, ACP.245, ACP.246, ACP.247, ACP.254, ACP.255, ACP.257, ACP.259, ACP.260, ACP.261, ACP.265, ACP.267, ACP.272, ACP.276, ACP.278, ACP.279, ACP.280, ACP.281, ACP.283, ACP.285, ACP.287, ACP.289, ACP.292, ACP.293, ACP.294, ACP.299, ACP.300, ACP.301, ACP.303, ACP.304, ACP.306, ACP.307, ACP.308, ACP.309, ACP.316, ACP.317, ACP.319, ACP.320, ACP.321, ACP.322, ACP.324, ACP.325, ACP.326, ACP.327, ACP.329, ACP.332, ACP.333, ACP.337, ACP.341, ACP.342, ACP.345, ACP.346, ACP.347, ACP.350, ACP.351, ACP.352, ACP.359, ACP.374, ACP.377, ACP.383, ACP.390, ACP.391, ACP.392, ACP.402, ACP.404, ACP.411, ACP.412, ACP.416, ACP.421, ACP.422, ACP.428, ACP.430, ACP.434, ACP.441, ACP.442	273

Based on the official FDA remedy

What to do — step by step

Check Module Serial Number
Look for serial numbers starting with AML.001 or FLX.0104 through FLX.103 on the interface module.
Contact Inpeco
Reach out to Inpeco S.A. for guidance on next steps if you have the recalled module.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 26 states.

FDA distribution: “Worldwide distribution - US Nationwide including in the states of Texas, West Virginia, South Carolina, Delaware, Louisiana, Illinois, Georgia, Florida, New York, Virginia, Arkansas, Wisconsin, California, Minnesota, Missouri, North…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Delaware, Florida, Georgia, Hawaii, Illinois, Kansas, Louisiana, Michigan, Minnesota, Missouri, New York, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

Apr 7, 2020Firm started the recall
May 14, 2020FDA classified it Class II
May 20, 2020Published in FDA’s Enforcement Report
Jul 28, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/65469-inpeco-flexlab-c8000-c16000-interface-module-recall-cross-contamination-risk">Inpeco FlexLab c8000/c16000 Interface Module Recall: Cross Contamination Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2003-2020 (April 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2003-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.