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Biomerieux Inc recalls API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identifica
Recalled February 2, 2022 · FDA recall Z-0525-2022 · Biomerieux
Hazard
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect. · FDA Class II
Units
462 kits
Sold at
US (Domestic) Distribution to states of: AZ, IA, KY, and NY.
Description
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
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.
Manufacturer(s)
Biomerieux Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →