FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Recall
- Recall Number
- Z-0087-2022
- Event Number
- 88700
- Firm
- Inpeco S.A. Via San Gottardo 10 Lugano Switzerland
- FEI Number
- 3010825766
- Product Code
- CEM
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- September 10, 2021
Description
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
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.
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.
Domestic distribution nationwide . Foreign distribution worldwide.
262 total, 52 US