CLASS III ONGOING Device recall · Reported 6 Mar 2024 · FDA Enforcement Report
In-vitro diagnostic kits: Abbott Vysis / CEP 12 FISH Probe Kit recalled
Abbott Molecular is recalling In-vitro diagnostic kits: Abbott Vysis / CEP 12 FISH Probe Kit, 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
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-1188-2024
- 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 MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
Where it was distributed
US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
Nationwide AlabamaCaliforniaIllinoisMassachusettsMarylandMinnesotaNew YorkPennsylvania
Questions about this recall
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 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.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 93902This product is part of a recall event; the main page for the event is Wash station: M1000 Wash Station Assembly & DITI Slide recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Wash station: M1000 Wash Station Assembly & DITI Slide recalled | Abbott Molecular | Hidden Drug Ingredients | Nationwide | |
| CLASS III | In-vitro diagnostic kits: Abbott Vysis LSI ATM recalled | Abbott Molecular | Hidden Drug Ingredients | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | Abbott Alinity m STI AMP Kit, used with the Alinity m System recalled | Abbott Molecular | Potency & Assay | Nationwide |
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| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |