The Recall Desk

FDA (Devices) recall action 67820

BioMerieux SA recalled 4 products on 2014-04-30

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2014-04-30
Critical
0
Units
135,412

Why these products were recalled

bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2014-04-30

    BioMerieux Recalls FB Reagent Due to False Negative Test Results

    BioMerieux SA is recalling FB Reagent (REF 70562) and ZYM B reagent (REF 70493) because a visual defect and activity issue can cause false negative results in Rapid ID 32 and API biochemical tests.

    Product
    FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests…
    Category
    Distribution
    52 states
  • ModerateFDA (Devices)··2014-04-30

    BioMerieux Recalls ZYM B Reagent Due to Visual Defect and Activity Issue

    BioMerieux SA is recalling ZYM B Reagent (REF 70493) because a visual defect and activity issue can cause false negative results in microbiological tests.

    Product
    ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species…
    Category
    Distribution
    52 states
  • ModerateFDA (Devices)··2014-04-30

    BioMerieux Recalls ZYM B and FB Reagents Due to False Negative Results

    BioMerieux is recalling ZYM B and FB reagents because a visual defect and activity issue can cause false negative results in Rapid ID 32 strips and API biochemical tests.

    Product
    API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
    Category
    Distribution
    52 states
  • HighFDA (Devices)··2014-04-30

    BioMerieux Recalls ZYM B and FB Reagents Due to False Negative Results

    BioMerieux is recalling ZYM B and FB reagents because a visual defect and activity issue caused false negative results in Rapid ID 32 strips and API biochemical tests.

    Product
    API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
    Category
    Distribution
    52 states