FDA-Device2021-10-20Class II
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
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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