ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized bioch

FDA device recall Z-1475-2014 · posted 2014-04-18 · Terminated

Recall details

Recalling firm

BioMerieux SA

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

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.

Root cause

Other

Status

Terminated

Product code

LIB

Quantity affected

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,

Date initiated

2014-03-06

Date posted

2014-04-18

Date terminated

2017-03-14

Location

Marcy L'Etoile, France