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Recall Observatory FDA recall evidence

Device product

Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)

Z-1190-2024

February 01, 2024

Class III

Product summary

Firm
Abbott Molecular, Inc.
Event
Event 93902
Status
Ongoing
Classification
Class III
Quantity
Unavailable
Official record key
device-enforcement:Z-1190-2024

Official wording

Reason: Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.

Code information: No lot number, UDI-DI 00884999006676.

Distribution pattern: US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.