FDA Enforcement
Class III
Ongoing
Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
Recall: Z-1190-2024
·
Reported March 6, 2024
Enforcement
- Recall Number
- Z-1190-2024
- Event ID
- 93902
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Abbott Molecular, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 6, 2024
- Initiation Date
- February 1, 2024
- Classification Date
- February 26, 2024
- Address
- 1300 E Touhy Ave, Des Plaines, IL, 60018-3315, United States
Description
Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
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 Info
No lot number, UDI-DI 00884999006676.
Distribution
US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.