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U.S. Department of Health and Human Services

Class 3 Device Recall Abbott

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  Class 3 Device Recall Abbott see related information
Date Initiated by Firm February 01, 2024
Date Posted February 26, 2024
Recall Status1 Open3, Classified
Recall Number Z-1188-2024
Recall Event ID 93902
Product Classification Dna-probe kit, human chromosome - Product Code OYU
Product In-vitro diagnostic kits:

(1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010;
(2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
Code Information (1) REF 01N15-010 - GTIN 00884999035362, Lot #381146, Exp. 2024-05-05; #381870, Exp. 2024-05-05; #382179 Exp. 2024-05-05; #387021, Exp. 2024-08-01; #528081, exp. 2023-11-16; (2) REF 01N34-020 - GTIN 00884999000766, Lot #522756, Exp. 2023-06-21.
Recalling Firm/
Manufacturer
Abbott Molecular, Inc.
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information Contact Ray Bastian
224-361-7000
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 16 kits
Distribution US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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