API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized sy...
FDA Recall #Z-0525-2022 — Class II — December 20, 2021
Product Description
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.
Recalling Firm
Biomerieux Inc — Hazelwood, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
462 kits
Distribution
US (Domestic) Distribution to states of: AZ, IA, KY, and NY.
Code Information
Model No. 32200; Lot 1008781060.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated