FDA recall Z-0525-2022

Biomerieux Inc · Class II · device

Product

API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either automatically or manually and the identification is obtained using an identification software.

Reason for recall

Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.

Distribution

US (Domestic) Distribution to states of: AZ, IA, KY, and NY.

Key facts

Status
Terminated
Initiation date
2021-12-20
Report date
2022-02-02
Termination date
2023-09-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hazelwood, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0525-2022