The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2817-2018·Announced 2018-08-29

bioMerieux VITEK 2 Gram Positive Test Kits Recalled for MRSA Detection Issues

bioMerieux is recalling VITEK 2 Gram Positive Test Kits because customer reports indicated an increased rate of non-detected MRSA.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product."

Plain-English summary

bioMerieux, Inc. is recalling specific VITEK 2 Gram Positive Test Kits, including the AST-P631, AST-GP67, AST-GP71, AST-GP75, and AST-GP78 models. These products are components for an automated in vitro diagnostic system used for the identification and antimicrobial susceptibility testing of bacteria and yeast.

The recall was initiated after customer reports indicated an increase in the rate of non-detected MRSA (Methicillin-resistant Staphylococcus aureus) in association with the VITEK 2 AST-P631 product. The affected units include multiple Gram Positive Cards with Oxacillin and Cefotoxin across all lots for the listed test kits.

The affected products were distributed worldwide, including in the United States, Puerto Rico, Bermuda, Brazil, Canada, China, and numerous other countries. Healthcare facilities and laboratories that use these diagnostic systems should stop using the affected test kits and contact bioMerieux for further instructions.

The recalled product

Product
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit…
Manufacturer
bioMerieux, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
13,961,320

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • VITEK 2 AST-P631
  • Ref # 414961 UDI 03573026426804 OXSF
  • OXSF
  • Ref: # 22226 UDI 03573026242060
  • OX
  • multiple Gram Positive Cards
  • all lots of cards with Oxacillin and Cefotoxin. VITEK 2 AST-GP71 Test Kit
  • Ref: #410750 UDI 03573026355173
  • all lots of cards with Oxacillin and Cefotoxin. VITEK 2 AST-GP75 Test Kit
  • Ref: #415670 UDI 03573026437183
  • all lots of cards with Oxacillin and Cefotoxin. VITEK 2 AST-GP78 Test Kit
  • Ref: #421051 UDI 03573026553982
  • all lots of cards with Oxacillin and Cefotoxin.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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