API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniat

FDA device recall Z-0756-2016 · posted 2016-02-04 · Terminated

Recall details

Recalling firm

BioMerieux SA

Reason for recall

Discrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests of the strips linked to the ZYM B reagent.

Action taken

BioMrieux sent an Urgent Field Safety Notice letter DATED jANUARY 8, 2015 to affected customers. The letter identified the affected product, problem and action to be taken. dated . The letter indicated that they could continue to use product in inventory with mandatory requirements that before using a ZYM B ampule and each day of use of API strips that they perform a quality control with ATCC strains as described in each package insert of involved API strips. The letter also requested that they distribute this letter to all appropriate personnel in the laboratory, retain a copy for their files, and forward the information to all parties that may use the product. For additional assistance or have any questions, contact your local bioMrieux Customer Service representative.

Root cause

Other

Status

Terminated

Product code

LIB

Quantity affected

13,271

Distribution

Nationwide Distribution in the states of: AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TX, VT, VA, WA, WV, WI

Date initiated

2016-01-08

Date posted

2016-02-04

Date terminated

2017-07-14

Location

Marcy L'Etoile, France