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Recall Observatory FDA recall evidence

Device product

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

Z-0087-2014

September 06, 2013

Class II

Product summary

Firm
bioMerieux, Inc.
Event
Event 66290
Status
Terminated
Classification
Class II
Quantity
90
Official record key
device-enforcement:Z-0087-2014

Official wording

Reason: 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.

Code information: Lot 1002234210 and 1002300040

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Salmonella colonies not being detected