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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK(R) 2 ASTP655

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 Class 2 Device Recall VITEK(R) 2 ASTP655see related information
Date Initiated by FirmAugust 13, 2018
Create DateSeptember 15, 2018
Recall Status1 Terminated 3 on November 02, 2020
Recall NumberZ-3180-2018
Recall Event ID 80860
Product Classification Enzyme immunoassay, gentamicin - Product Code LCD
ProductVITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product Usage: 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 Lot Numbers: 8050348103, 8050452403, 8050655403, 8050690403
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact
919-620-2000
Manufacturer Reason
for Recall		Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparations (solutions).
FDA Determined
Cause 2		Process control
ActionThe firm initiated the recall by email on 08/13/2018. The firm requested the consignee discard the impacted product and contact the local bioMerieux representative for credit.
Quantity in Commerce10919 cartons
DistributionWorldwide Distribution US Nationwide and the countries of: Turkey, Austria, Switzerland, Czech Republic, Germany, Netherlands,
Total Product Life CycleTPLC Device Report
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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