Z-2817-2018Class I

bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS...

Name: Z-2817-2018 bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS...
Creator: bioMerieux, Inc.
Published: 2018-01-26
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2018-01-26 / Terminated

FDA source

bioMerieux, Inc. began a recall of bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for... on 2018-01-26. FDA classified it as Class I and 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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2817-2018
Classification: Class I
Status: Terminated
Initiated: 2018-01-26
Posted: 2018-08-30
Terminated: 2019-05-20
Recalling firm: bioMerieux, Inc.
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 bioMerieux VITEK 2 AST-GP75 Test Kit bioMerieux VITEK 2 AST-GP78 Test Kit Components for an automated invitro diagnostic system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
FDA root cause: Under Investigation by firm
Action: bioMerieux sent an Urgent Product Correction Notice letter to their French customers on January 26, 2018. Customer letters in the Americas were sent August 21, 2018. The letters identified the affected product, problem, and actions to be taken. Customers should follow steps outlined in the letter and contact bioMerieux for any additional questions regarding these corrective actions. Note: the actions do not include removal of the product. For any questions or concerns, contact your local bioMerieux representative.
Quantity in commerce: 13,961,320 US
Distribution: Worldwide distribution. US nationwide including Puerto Rico, Bermuda, Brazil, Canada, China, Curacao, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Indonesia, Israel, Hong Kong, South Korea, South Africa, Mexico, Myanmar, Nicaragua, Peru, Philippines, Paraguay, Singapore, Thailand, El Salvador, and Vietnam.
Product codes and lots: VITEK 2 AST-P631, Ref # 414961 UDI 03573026426804 OXSF, multiple Gram Positive Cards all lots of cards with Oxacillin and Cefotoxin OX, OXSF, multiple Gram Positive Cards all lots of cards with Oxacillin and Cefotoxin VITEK 2 AST-GP67 Test Kit, Ref: # 22226 UDI 03573026242060, OX, OXSF, multiple Gram Positive Cards, all lots of cards with Oxacillin and Cefotoxin. VITEK 2 AST-GP71 Test Kit, Ref: #410750 UDI 03573026355173, OX, OXSF, multiple Gram Positive Cards, all lots of cards with Oxacillin and Cefotoxin. VITEK 2 AST-GP75 Test Kit, Ref: #415670 UDI 03573026437183, OX, OXSF, multiple Gram Positive Cards, all lots of cards with Oxacillin and Cefotoxin. VITEK 2 AST-GP78 Test Kit, Ref: #421051 UDI 03573026553982, OX, OXSF, multiple Gram Positive Cards, all lots of cards with Oxacillin and Cefotoxin.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2817-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2817-2018	Class I	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17

Product code LON

K053097Class IIVitek 2 Gram Positive Cefoxitin ScreenbioMerieux, Inc. / cleared 2005-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)