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Recall Observatory FDA recall evidence

Device product

Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device

Z-1947-2025

May 01, 2025

Class II

Product summary

Firm
Remel, Inc
Event
Event 96810
Status
Ongoing
Classification
Class II
Quantity
70 units
Official record key
device-enforcement:Z-1947-2025

Official wording

Reason: Product may have an off color affecting perfomance

Code information: UDI/DI 848838018855, lot 226414

Distribution pattern: Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product may have an off color affecting perfomance