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Recall Observatory FDA recall evidence

Device product

remel THIOGLYCOLLATE MEDIUM, REF 05152

Z-3019-2018

August 13, 2018

Class II

Product summary

Firm
Remel Inc
Event
Event 80813
Status
Terminated
Classification
Class II
Quantity
48 units
Official record key
device-enforcement:Z-3019-2018

Official wording

Reason: Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.

Code information: Lot number: 258192

Distribution pattern: US, Canada, Singapore

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.