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Recall Observatory FDA recall evidence

Device product

Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates). Blood agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.

Z-1748-2015

May 04, 2015

Class II

Product summary

Firm
Remel Inc
Event
Event 71198
Status
Terminated
Classification
Class II
Quantity
845/10/10-plate pack cases
Official record key
device-enforcement:Z-1748-2015

Official wording

Reason: Product may be contaminated with Listeria monocytogenes.

Code information: Lot Number: 646595 and 646596 Expiration date: 19May2015

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    contaminated with Listeria monocytogenes