Abbott Molecular, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1188-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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;

Product Classification:

Class III

Date Initiated: February 1, 2024

Date Posted: March 6, 2024

Recall Number: Z-1188-2024

Event ID: 93902

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.

Status: Ongoing

Product Quantity: 16 kits

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated