Recall Z-1475-2014
BioMerieux SA · initiated March 6, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 identifications of microorganisms.
Codes / lots: Codes - 1002706740, Exp. Date 10/14/2014, 1002717860, Exp. Date 10/24/2014, 1002742610, Exp. Date 10/30/2014, 1002760700, Exp. Date 11/4/2014, 1002821420, Exp. Date 11/26/2014, 1002857840, Exp. Date 12/12/2014, 1002860530, Exp. Date 12/12/2014
Reason for recall
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
FDA-determined cause: Other
Action taken
Letters were issued to customers on March 10, 2014. The letter contained instructions to be used if they still were using the product. The letter also included a report form which was to be returned.
Details
- Recall number
- Z-1475-2014
- Initiated
- March 6, 2014
- Posted by FDA
- April 18, 2014
- Terminated
- March 14, 2017
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- Quantity
- 33,853
- Distribution
- Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WV, WA, WI, and WY and the country of Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Benin…
- Recalling firm
- BioMerieux SA, Marcy L'Etoile
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1476-2014 Class II | FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results…bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent… | 03/06/2014Terminated |
| Z-1477-2014 Class II | API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and…bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent… | 03/06/2014Terminated |
| Z-1478-2014 Class II | API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF…bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent… | 03/06/2014Terminated |