Food, drugs, devices › Biomerieux Inc
Device recall: Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the V
FDA enforcement event 70645 is a device recall by Biomerieux Inc of Hazelwood, MO, initiated 25 Feb 2015 and classified Class III, with 3 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 22 Mar 2017. 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 outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use."
Distribution
"Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1401-2015 | Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae. | 10409 cartons | Class III | Terminated | 15 Apr 2015 |
| Z-1402-2015 | Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae. | 2053 cartons | Class III | Terminated | 15 Apr 2015 |
| Z-1403-2015 | Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae. | 1505 cartons | Class III | Terminated | 15 Apr 2015 |
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 outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Mar 2017. "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.