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Recall Observatory FDA recall evidence

Device product

Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.

Z-0284-2019

August 02, 2018

Class III

Product summary

Firm
Acumedia Manufacturers, Inc.
Event
Event 81107
Status
Terminated
Classification
Class III
Quantity
93 bottles
Official record key
device-enforcement:Z-0284-2019

Official wording

Reason: The product is labeled with an incorrect expiration date.

Code information: lot #110685B

Distribution pattern: US Distribution to states of: FL, TN; and internationally to countries of: Brazil, and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product is labeled with an incorrect expiration date.