Lower riskMedical device recall · FDA · Published August 7, 2020
Inpeco Accelerator a3600 System Recall: Incorrect Lab Results Risk
Inpeco recalls Accelerator a3600 systems with Sysmex XN-9000/XN-9100 Interface Modules that may mis-associate sample IDs, causing incorrect or delayed lab results. Affected units have specific serial numbers.
Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
Take action
Contact the company
📍Recalling firmInpeco S.A.Via San Gottardo 10 · Lugano, Switzerland
“Inpeco Accelerator a3600 System Recall: Incorrect Lab Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64509-inpeco-accelerator-a3600-system-recall-incorrect-lab-results-risk. Based on FDA recall #Z-2974-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2974-2020%22&limit=1).
The FDA announced on Aug. 7, 2020, that Inpeco S.A. is recalling Accelerator a3600 systems with specific Sysmex Interface Modules and Track to Rack Modules due to firmware errors that may cause incorrect or delayed test results. The recall affects units distributed worldwide.
How to tell if you have it
Brand: Inpeco
Product: Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10-
Serial Numbers (US): ACP.413, ACP.424
Serial Numbers (OUS): ACP.349, ACP.399, ACP.400, ACP.410, ACP.252, ACP.290
The hazard
According to the FDA, the firmware of the Sysmex XN-9000/XN-9100 Interface Module and the Track to Rack Module has the potential to mis-associate sample IDs. This error can lead to incorrect results or delayed results.
Context
GovInfoNow's records show Inpeco S.A. has had 13 other recalls on record since Feb. 13, 2018. Other recent recalls of similar products include Inpeco FlexLab FLX-217-40 (Oct. 30, 2025), Inpeco FlexLab Potassium Test System Recall (Sept. 3, 2025), and Roche Cobas 8000 Interface Module Recall (Nov. 3, 2023). Other recent recalls of similar products include Beckman Coulter AU5800 Chemistry Analyzer Recall (Jan. 30, 2026), Beckman Coulter DxC 700 AU Recall (Jan. 30, 2026), and Baxter Novum IQ Syringe Pump Recall (Aug. 11, 2026).
How to tell if you have this one
Check if your Accelerator a3600 system has the Sysmex XN-9000/XN-9100 Interface Module with serial numbers starting with ACP.413, ACP.424, ACP.349, ACP.399, ACP.400, ACP.410, ACP.252, or ACP.290.
Brand
Inpeco
Category
Medical device
FDA recall event · 3 products
All 3 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 distribution including in the states of AK, FL, IA, LA, MA, MS, MT, NC, OH, TX, VA and the countries of AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, NETHERLANDS. NORWAY SAUDI ARABIA SOUTH KOREA SWEDEN UNITED ARAB EMIRATES
Recall number
Product, codes & lots
Quantity
Z-2973-2020
FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab 3.6 Automation 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 system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.; Serial Numbers: US: FLX.0133 FLX.0181 OUS: FLX.0048 FLX.0049 FLX.0121 FLX.0155 FLX.0160 FLX.0200
2 US and 6 OUS
Z-2974-2020
Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation 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 system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.; Serial Numbers: US: ACP.413 ACP.424 OUS: ACP.349 ACP.399 ACP.400 ACP.410 ACP.252 ACP.290
2 US and 6 OUS
Z-2975-2020
Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation 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 system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.; Serial Numbers: US: AP2.0111 AP2.0137 AP2.0190 AP2.0191 AP2.0290 AP2.0296 AP2.0321 AP2.0322 AP2.0349 AP2.0385 AP2.0398 OUS: AP2.0111 AP2.0113 AP2.0143 AP2.0170 AP2.0225 AP2.0242 AP2.0250 AP2.0259 AP2.0265 AP2.0270 AP2.0285 AP2.0295 AP2.0316 AP2.0350 AP2.0382 AP2.0388 AP2.0389 AP2.0390 AP2.0392 AP2.0448 APT.0058 APT.0065
10 US and 22 OUS
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Verify if your system has serial numbers starting with ACP.413, ACP.424, ACP.349, ACP.399, ACP.400, ACP.410, ACP.252, or ACP.290.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AK, FL, IA, LA, MA, MS, MT, NC, OH, TX, VA and the countries of AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, NETHERLANDS. NORWAY SAUDI…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Florida, Iowa, Louisiana, Massachusetts, Mississippi, Montana, North Carolina, Ohio, Texas, Virginia.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2974-2020 (August 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2974-2020 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.