FDA-Device2021-10-20Class II
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Inpeco S.A.
Hazard
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.
Sold states
Domestic distribution nationwide . Foreign distribution worldwide.
Affected count
262 total, 52 US
Manufactured in
Via San Gottardo 10, N/A, Lugano, N/A, Switzerland
Products
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0087-2022Don't want to check this manually?
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