API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identifica
Summary
The FDA issued a Class II for API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitativ by Biomerieux Inc. Reason: Risk of misidentification or delayed results with the absence of identification due to thermoforming defect..
Details
Source
Device Recall
External ID
Z-0525-2022
Action Date
2022-02-02
Status
Terminated
Category
device
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.
Lot/Code Info: Model No. 32200; Lot 1008781060.
Quantity Affected: 462 kits
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-20
Company
Hazelwood, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 97 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Biomerieux Inc has 146 FDA actions in our database, including 122 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Biomerieux Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Biomerieux Inc have FDA actions?
Biomerieux Inc has 146 FDA actions in our database, including 122 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0525-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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