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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK 2 CARD ASTN371

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 Class 2 Device Recall VITEK 2 CARD ASTN371see related information
Date Initiated by FirmFebruary 05, 2020
Create DateMarch 20, 2020
Recall Status1 Terminated 3 on October 28, 2022
Recall NumberZ-1534-2020
Recall Event ID 84993
Product Classification unknown device name - Product Code N/A
ProductVITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.
Code Information REF: 422024 Lot Number: 0210932204
FEI Number 3002769706
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information ContactbioMerieux Support Operations
800-682-2666
Manufacturer Reason
for Recall		The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
FDA Determined
Cause 2		Process control
ActionbioMerieux notified customers on about 02/05/2020 via "Urgent Product Correction Notice." The letter requested customers to check their inventory, destroy any recalled product, ensure the recall notice has been distributed to all appropriate personnel within your organization, and complete and return the attached Acknowledgement form.
Quantity in Commerce4,130 kits (82,600 cards)
DistributionInternational distribution in the countries of Germany and the Netherlands.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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