FDA recall Z-0087-2022

Product

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.

Distribution

Domestic distribution nationwide . Foreign distribution worldwide.

Key facts

Status

Ongoing

Initiation date

2021-09-10

Report date

2021-10-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lugano, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0087-2022