CLASS III ONGOING Device recall · Reported 6 Mar 2024 · FDA Enforcement Report

In-vitro diagnostic kits: Abbott Vysis LSI ATM recalled

Abbott Molecular is recalling In-vitro diagnostic kits: Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, distributed nationwide in the US. The recall was initiated on 1 Feb 2024 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codes(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.

Quantity recalled7 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1189-2024
FDA event ID: 93902
Recalling firm: Abbott Molecular, Des Plaines, IL
Classification: Class III
Status: Ongoing
Recall initiated: 1 Feb 2024
FDA classified: 26 Feb 2024
Reported: 6 Mar 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Hidden Drug Ingredients
Device type: Test Kits & Diagnostics

Timeline

1 Feb 2024	Recall initiated by company
26 Feb 2024	Classified by FDA	+25 days
6 Mar 2024	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.

Product as listed by the FDA

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;

Where it was distributed

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

Nationwide Alabama California Illinois Massachusetts Maryland Minnesota New York Pennsylvania

Questions about this recall

Is In-vitro diagnostic kits: Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe recalled?

Yes. Abbott Molecular recalled In-vitro diagnostic kits: Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe on 1 Feb 2024. The recall is Class III and its status is Ongoing. Recall number Z-1189-2024.

Why was it recalled?

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.

Which lots are affected?

(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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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