Abbott Molecular, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1189-2024)

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 LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001; (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe, REF 05J03-004; (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe, REF 05J04-022;

Product Classification:

Class III

Date Initiated: February 1, 2024

Date Posted: March 6, 2024

Recall Number: Z-1189-2024

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: 7 kits

Code Information:

(1) REF 01N33-020 - GTIN 00884999000759, Lot #381411, Exp. 2024-09-22; (2) REF 04N62-020 - GTIN 00884999009301, Lot #382133, Exp. 2024-05-25; (3) REF 05J03-001 - GTIN 00884999009882, Lot #381111, Exp. 2024-06-17; (4) REF 05J03-004 - GTIN 00884999009912, Lot #381102, Exp. 2024-06-17; (5) REF 05J04-022 - GTIN 00884999010451, Lot #530242, Exp. 2024-03-28.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated