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Recall Observatory FDA recall evidence

Device product

Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples.

Z-2584-2017

November 30, 2015

Class II

Product summary

Firm
Acumedia Manufacturers, Inc.
Event
Event 77283
Status
Terminated
Classification
Class II
Quantity
28 units
Official record key
device-enforcement:Z-2584-2017

Official wording

Reason: Contamination of product with possible Bacillus spp

Code information: PN 7987, Lot 108044

Distribution pattern: Worldwide Distribution - US Nationwide in the states of WI, NJ, NY and countries of BRAZIL, ECUADOR, SINGAPORE, CANADA,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Contamination of product with possible Bacillus spp