Z-1188-2024Class III

In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI...

Name: Z-1188-2024 In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI...
Creator: Abbott Molecular, Inc.
Published: 2024-02-01
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2024-02-01 / Open, Classified / root cause: manufacturing process

FDA source

Abbott Molecular, Inc. began a recall of 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... on 2024-02-01. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1188-2024
Classification: Class III
Status: Open, Classified
Initiated: 2024-02-01
Posted: 2024-02-26
Recalling firm: Abbott Molecular, Inc.
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;
Product code: OYU Dna-Probe Kit, Human Chromosome
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: (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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1188-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1188-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-26
Z-1189-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-26
Z-1190-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-26

Product code OYU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)