FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Reported: October 20, 2021 Initiated: September 10, 2021 #Z-0087-2022
Product Description
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
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.
Details
- Recalling Firm
- Inpeco S.A.
- Units Affected
- 262 total, 52 US
- Distribution
- Domestic distribution nationwide . Foreign distribution worldwide.
- Location
- Lugano, N/A
Frequently Asked Questions
What product was recalled? ▼
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.). Recalled by Inpeco S.A.. Units affected: 262 total, 52 US.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0087-2022.
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