FDA-Device2022-02-02Class II
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.
Biomerieux Inc
Hazard
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
Sold states
US (Domestic) Distribution to states of: AZ, IA, KY, and NY.
Affected count
462 kits
Manufactured in
595 Anglum Rd, Hazelwood, MO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0525-2022Don't want to check this manually?
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