FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
FDA Recall Z-0087-2022 · Posted None
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Recalling FirmInpeco S.A.
Recall StatusOpen, Classified
Product CodeCEM
Date Initiated2021-09-10
Product Quantity262 total, 52 US
Reason for 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.
Firm Action
On September 10, 2021, the firm distributed "Urgent IVD Medical Device Correction" letters to affected consignees. Distributors were instructed to forward the recall communication to downstream customers.
Customers were informed that the potential risk associated with the issue is related to an incorrect patient result that may lead to incorrect patient treatment.
Users were provided with detailed instructions on precautions to avoid the occurrence of the described issue, including a daily visual check and what to do in case of error 3160 or 0D60.
Contact your local technical support provider if you need assistance implementing these actions.
Your service provider will contact you to schedule the firmware upgrade of the Automation System Interface Module to ADVIA Centaur XP/XPT. Until then, please maintain awareness of this recall and follow precautions provided by the firm.
If you have any questions about this recall, please contact Eva Balzarotti, Regulatory Affairs Manager at [email protected]. Phone number: (+41) 91 9118 224.
Root Cause
Software design
Distribution Pattern
Domestic distribution nationwide . Foreign distribution worldwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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