Summary
The FDA issued a Class II for VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226 by Biomerieux Inc. Reason: As the temperature and time out of range was exceeded, product performances cannot be guaranteed.
Details
Source
Device Recall
External ID
Z-0792-2023
Action Date
2023-01-11
Status
Ongoing
Category
device
Product Description
VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226
Lot/Code Info: UDI/DI 03573026242060, Batch Numbers: 1322258403
Quantity Affected: 15 units
Reason for Recall
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-09
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 162 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-0792-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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