Inpeco FlexLab, Accelerator a3600, Aptio Automation Recall: Incorrect Patient Test Results
Inpeco recalls FlexLab, Accelerator a3600, and Aptio Automation systems due to firmware issues causing incorrect patient test results. Affected units include specific serial numbers and part numbers.
Lower-risk recall
The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.
Contact the company
What happened, in plain English
Inpeco is recalling FlexLab, Accelerator a3600, and Aptio Automation systems because outdated firmware may link test results to the wrong patient samples. This could lead to incorrect patient diagnoses if not fixed. Read more at govinfonow.com/recall/61809-inpeco-flexlab-accelerator-a3600-aptio-automation-recall-incorrect-patient-test.
Source Summary by GovInfoNow · govinfonow.com/recall/61809-inpeco-flexlab-accelerator-a3600-aptio-automation-recall-incorrect-patient-test · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0087-2022
Cite this page
“Inpeco FlexLab, Accelerator a3600, Aptio Automation Recall: Incorrect Patient Test Results.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/61809-inpeco-flexlab-accelerator-a3600-aptio-automation-recall-incorrect-patient-test. Based on FDA recall #Z-0087-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0087-2022%22&limit=1).
Why it’s dangerous
The firmware in the Automation System Interface Module may incorrectly match test results to the wrong patient sample ID. This could cause misdiagnosis if the system fails to properly track samples during testing.
Who’s affected
Healthcare facilities using the affected models of Inpeco automation systems are most at risk. Patients could receive incorrect test results if the system misassociates samples.
How to tell if you have this one
Check if your system has the FlexLab (FLX) serial numbers listed above, or Accelerator a3600 (ACP) part number ACP.334, or Aptio Automation (AP2) part numbers starting with AP2.0002.
- Brand
Inpeco- Category
Medical device
What to do — step by step
Check Your System Model
Identify if your system matches the FlexLab, Accelerator a3600, or Aptio Automation models listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Domestic distribution nationwide . Foreign distribution worldwide.” 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 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0087-2022 (September 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0087-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.