ZYM B Reagent (REF 70493) 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 identifications of microorganisms.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot numbers: 1002171010, 1002295110, 1002360360, 1002421440, 1002485410, 1001951820, 1002011320, and 1002071020.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Biomerieux France Chemin De L'Or
Reason for Recall:
bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

ZYM B Reagent (REF 70493) 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 identifications of microorganisms.

Product Codes/Lot Numbers:

Lot numbers: 1002171010, 1002295110, 1002360360, 1002421440, 1002485410, 1001951820, 1002011320, and 1002071020.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0841-2014

Related Recalls

Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.

Apr 15, 2016 Diagnostic Equipment Nationwide View Details →

bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.

Nov 8, 2013 Diagnostic Equipment Nationwide View Details →

bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.

Nov 8, 2013 Diagnostic Equipment Nationwide View Details →