Use caution Medical device recall · FDA · Published March 10, 2023

Inpeco FlexLab Lab Automation System Recall: Risk of Incorrect Patient Electrolyte Results

Inpeco recalls FlexLab and related lab automation systems due to firmware issues that may cause incorrect electrolyte test results, potentially leading to serious health risks if not addressed.

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

🇺🇸 FDA recall #Z-1560-2023Medical device Inpeco ›

Use caution until it’s fixed

Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can result in CNS disturbances and disturbances of water balance. Abnormal chloride levels can lead to acid base disturbances which can lead to respiratory and cardiac compromise. The event may occur only if all the following conditions occurs in few milliseconds timeframe: - The module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the module buffer lane due to a malfunction of the divert gate Only in this specific scenario, the Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without any error message. The Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the test orders not performed yet on Tube B. Inpeco has released a Technical Service Bulletin with the procedure to correctly update the firmware. The firmware upgrade will be performed by Field Service Engineers. A CAPA (Corrective Action Preventive Action) has been opened to deeply investigate the root cause and identify possible process lack in order to avoid reoccurrences.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Inpeco is recalling its FlexLab laboratory automation systems because outdated firmware can misidentify sample tubes, leading to incorrect electrolyte test results. This could cause improper treatment or failure to treat abnormal results, risking serious health issues like cardiac problems or death. Read more at govinfonow.com/recall/58765-inpeco-flexlab-lab-automation-system-recall-risk-of-incorrect-patient.

Source Summary by GovInfoNow · govinfonow.com/recall/58765-inpeco-flexlab-lab-automation-system-recall-risk-of-incorrect-patient · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1560-2023

Cite this page

“Inpeco FlexLab Lab Automation System Recall: Risk of Incorrect Patient Electrolyte Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58765-inpeco-flexlab-lab-automation-system-recall-risk-of-incorrect-patient. Based on FDA recall #Z-1560-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1560-2023%22&limit=1).

The FDA announced on March 10, 2023, that Inpeco S.A. is recalling its Storage and Retrieval Module (SRM)-Laboratory Automation systems due to firmware errors that may mis-associate sample IDs. This defect can lead to incorrect patient test results for sodium, potassium, and chloride levels.

How to tell if you have it

Brand: Inpeco
Product names: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2)
Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01, APT-207-00, APT-207-01, APT-230-00, APT-230-01, FLX-207-00, FLX-207-01, FLX-207-02, FLX-230-00, FLX-230-01, FLX-230-02, FLX-207-10, FLX-207-11, FLX-230-10
Firmware Versions: all versions
Units affected: 245 in the US

The hazard

The firmware has the potential to mis-associate sample IDs, leading to incorrect or delayed patient results for sodium, potassium, and chloride. Falsely increased or decreased electrolytes can result in inappropriate treatment of normal results or failure to treat abnormal results. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death.

Context

GovInfoNow's records show Inpeco S.A. has 13 other recalls on record since 2018-02-13. Recent brand recalls include the 2025-10-30 Inpeco FlexLab FLX-217-1 recall for mismatched labels and the 2025-09-03 Inpeco FlexLab X Potassium Test System Recall for risk of erroneous results. Other recent recalls of similar products include the 2026-07-29 Nova Biomedical StatStrip Glucose Meter System Recalls for patient data mismatch risk and the 2026-06-08 Siemens Atellica CH A1c_E Test Recall for false HbA1c results risk.

How to tell if you have this one

Check for the product names FlexLab (FLX), Accelerator a3600 (ACP), or Aptio Automation (AP2). Look for part numbers starting with ACP-207, APT-207, FLX-207, or FLX-230. The system was sold with firmware versions that are not updated.

Brand
Inpeco
Category
Medical device

FDA recall event · 5 products

All 5 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
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EAU, EGYPT, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, MALAYSIA, MEXICO, MYANMAR, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UK, VIETNAM.

Recall number	Product, codes & lots	Quantity
Z-1559-2023	Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11; FlexLab 07640172340004 Accelerator a3600 07640172341001 Aptio¿ Automation 07640172342008 Firmware Versions: GWC board: prior to 2-3-0. DDT board: all versions	US:245 (16 FlexLab systems, 121 Accelerator a3600 system, 108 Aptio Automation systems).
Z-1560-2023	Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 FLX-207-00, FLX-207-01, FLX-207-02, FLX-230-00, FLX-230-01, FLX-230-02 FLX-207-10, FLX-207-11, FLX-230-10; UDI: FlexLab 07640172340004 Accelerator a3600 07640172341001 Aptio¿ Automation 07640172342008 Firmware Versions: all versions	US: 245 (16 FlexLab systems, 121 Accelerator a3600 system, 108 Aptio Automation systems).
Z-1561-2023	PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A; UDI: FlexLab 07640172340004 Accelerator a3600 07640172341001 Aptio¿ Automation 07640172342008 Firmware Versions: All versions	US: 245 (16 FlexLab systems, 121 Accelerator a3600 system, 108 Aptio Automation systems).
Z-1562-2023	Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A; UDI: FlexLab 07640172340004 Accelerator a3600 07640172341001 Aptio¿ Automation 07640172342008 Firmware Versions: All versions	US: 245 (16 FlexLab systems, 121 Accelerator a3600 system, 108 Aptio Automation systems).
Z-1563-2023	Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20; UDI: FlexLab 07640172340004 Accelerator a3600 07640172341001 Aptio¿ Automation 07640172342008 Firmware Versions: All versions	US:245 (16 FlexLab systems, 121 Accelerator a3600 system, 108 Aptio Automation systems).

Based on the official FDA remedy

What to do — step by step

Contact Inpeco for Firmware Update
Inpeco field service engineers will update the firmware to correct the issue. Contact them directly for the update process.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EAU, EGYPT, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRELAND, ISRAEL,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Mar 10, 2023Firm started the recall
May 4, 2023FDA classified it Class II
May 10, 2023Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/58765-inpeco-flexlab-lab-automation-system-recall-risk-of-incorrect-patient">Inpeco FlexLab Lab Automation System Recall: Risk of Incorrect Patient Electrolyte Results (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-1560-2023 (March 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1560-2023 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.