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Terminated

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.

FDA Recall Z-0841-2014 · Posted 2014-01-27

Recalling FirmBiomerieux France Chemin De L'Or
Recall StatusTerminated
Date Initiated2013-11-08
Date Terminated2017-11-30
Product Quantity39439 kits (includes ZYM B reagents, API Listeria * API NH kits)

Reason for Recall

bioMrieux 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.

Firm Action

bioMerieux sent an Urgent Product Removal Notice letter dated November 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure the letter and guidance were distributed and received by all appropriate personnel in their organization, customers were instructed to discontinue use and destroy ZYM (B 70493), API NH (10400) API Listeria (10300) with ZYM B ampules having a visual defect. Customers still in possession of some kits of ZYM B (70493-Lots: 1) without visual defect that is used with API 20 Strep (20600), API Coryne (20900), API Staph (20500) and API ZYM (25200), have the option to: a) Use the kits of ZYM B (70493) still in your inventory with the following mandatory requirement for the API Strep and API Coryne: perform a daily quality control with the ATCC strain described in the paragraph Reading and Interpretation of the package insert of each API strip prior to using the ZYM B ampules. b) Use the kits of ZYM B (70493) still in your inventory without any requirement with API Staph and API ZYM, or c) Discard all kits of ZYM B (70493) still in their inventory. If you are still in possession of some kits of API NH (10400-Lots: See Annex 1) without visual defect of ZYM B, you have the option to: a) Use the kits of API NH (10400) still in your inventory with the mandatory requirement: perform a daily quality control with the ATCC strain 49917 Haemophilus paraphrophilus described in the paragraph Use of the reagents of the package insert of API NH prior to using the ZYM B ampules or, b) Discard all the kits of API NH (10400) still in your inventory. 5. If you are still in possession of some kits of API Listeria (10300-Lots: See Annex 1) without visual defect of ZYM B, we ask you to use the API Listeria (10300) still in your inventory with the mandatory requirement: perform a daily quality control with the ATCC strain 33090 Listeria innocua as

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to U.S. Nationwide; Algerie, Argentina, Armenia, Australia, Austria, Azerbaidjian, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bolivia, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chad, Chile, China, Colombia, Democratic Republic of Congo, Costa Rica, Cote d'Ivorie, Germany, Czech Republic, Dominican Republic, Dutch Antilles, Dutch Antilles, Ecuador, Egypt, Republica De El Salvador, Estonia, Germany, Ethiopia, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Germany, Indonesia, Iraq, Israel, Italy, Jamaica, Japan, Iraq, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malaysia, Malaysia, Mali, Malta, Mexico, Romania, Mongolia, Morocco, Mozambique, Singapore, Netherlands, Managua, Niamey Niger, Nigeria, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Uganda, Kingdom of Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Tanzania, Italy, Thailand, Trinidad & Tobago, Tunisia, Turkey, Uganda, Ukraine, UAE, United Kingdom, Uruguay, Venezuela, Vietnam, Vietnam, Yemen and Zimbabwe

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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