Abbott Molecular, Inc. Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.) Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
Brand
Abbott Molecular, Inc.
Lot Codes / Batch Numbers
No lot number, UDI-DI 00884999006676.
Products Sold
No lot number, UDI-DI 00884999006676.
Abbott Molecular, Inc. is recalling Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare due to Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customer. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026