Recall Z-1190-2024— Abbott Molecular, Inc.
Class III · Ongoing
Class III FDA medical device recall by Abbott Molecular, Inc., initiated 2024-02-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Abbott Molecular, Inc.
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2024-02-01
- Firm location
- Des Plaines, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.