Food, drugs, devices › Biomerieux Inc
Device recall: bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine th
FDA enforcement event 64327 is a device recall by Biomerieux Inc of Hazelwood, MO, initiated 6 Feb 2013 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 30 Oct 2013. 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, Hazelwood, MO.
Reason for recall
"The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements."
Distribution
"Distributed only in HI."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1013-2013 | bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents. | 4/20-card cartons | Class II | Terminated | 3 Apr 2013 |
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: "The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed only in HI."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Oct 2013. "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.