Recalls / —

—#121947

Product

chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens.

Affected lot / code info

Lot 1002234210 and 1002300040

Why it was recalled

Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored colonies. This could potentially lead to Salmonella colonies not being detected.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Recall letters were issued to the US customers by Biomeriux, Durham, NC on 9/6/2013.

Recalling firm

Firm

bioMerieux, Inc.

Address

100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern

Nationwide Distribution.

Timeline

Recall initiated

2013-09-06

Posted by FDA

2013-10-28

Terminated

2014-06-24

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #121947. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.