In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13

FDA device recall Z-1188-2024 · posted 2024-02-26 · Open, Classified

Recall details

Recalling firm

Abbott Molecular, Inc.

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

OYU

Quantity affected

16 kits

Distribution

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

Date initiated

2024-02-01

Date posted

2024-02-26

Location

Des Plaines, IL