Z-1190-2024 Class III Ongoing
FDA device recall Z-1190-2024 was initiated by Abbott Molecular, Inc. on February 1, 2024 and is designated Class III. Reason for recall: 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. The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2024
- Initiation Date
- February 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
Code Information
No lot number, UDI-DI 00884999006676.