Food, drugs, devices › bioMerieux, Inc.
Device recall: bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Suscep
FDA enforcement event 80619 is a device recall by bioMerieux, Inc. of Durham, NC, initiated 26 Jan 2018 and classified Class I, with 1 product record.
FDA defines Class I as 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. 4% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 20 May 2019. Initiation: voluntary: firm initiated. bioMerieux, Inc. has 57 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
bioMerieux, Inc., Durham, NC.
Reason for recall
"Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product."
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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2817-2018 | 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… | 13,961,320 US | Class I | Terminated | 29 Aug 2018 |
Context
Other enforcement events for bioMerieux, Inc.
All 57 events for bioMerieux, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution. US nationwide including Puerto Rico, Bermuda, Brazil, Canada, China, Curacao, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Indonesia, Israel, Hong Kong, South…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 May 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.