FDA Medical Device Recalls (openFDA)
Abbott Molecular, Inc.: Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
- Recall number
- Z-1190-2024
- Recalling firm
- Abbott Molecular, Inc.
- Product
- Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
- Status
- Open, Classified
- Initiated
- 2024-02-01
- Posted
- 2024-02-26
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- The recalling firm issued letters dated and issued on 2/1/2024 via FedEx priority overnight express mail. The letter explained the background, potential impact, and necessary actions to be taken and contained an appendix listing Impacted Abbott Products and an appendix listing CE products and similar US products. The actions to be taken were to destroy all remaining inventory of the impacted products and contact their local Abbott representative for replacements. If the product has been forwarded to other laboratories, the consignee is requested to inform them of the recall and have them take the necessary actions. The letter states that laboratories should follow internal procedures in regard to a lookback of results and a lookback should be considered if results have been released that are tied to performance claims. A Customer Reply Form was enclosed to acknowledge receipt of the letter. The consignee was to record the amount of affected product that was destroyed.
- Quantity
- not on file
- Distribution
- US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
- Lot, serial or model codes
- No lot number, UDI-DI 00884999006676.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OOI
- Firm FEI
- 3005248192
- Firm city
- Des Plaines
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28