FDA recall Z-1190-2024

Abbott Molecular, Inc. · Class III · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2024-02-01
Report date
2024-03-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Des Plaines, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1190-2024