Device recall: In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319…
Class III FDA enforcement event 93902. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Abbott Molecular, Inc. started this device recall on 1 Feb 2024. The firm address in the FDA record is in Des Plaines, IL. FDA put the recall in Class III. FDA event 93902 has 3 product records. The first FDA enforcement report date is 6 Mar 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
Recalling firm
Abbott Molecular, Inc., Des Plaines, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1188-2024 | 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; | 16 kits | Class III | Ongoing | 6 Mar 2024 |
| Z-1189-2024 | 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… | 7 kits | Class III | Ongoing | 6 Mar 2024 |
| Z-1190-2024 | Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.) | Class III | Ongoing | 6 Mar 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class III
- 2%
- Product records in this event
- 3Median of the firm: 1
- Events of the firm on the register
- 20
Other events of the firm
Official channels
- FDA enforcement report Z-1188-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 93902. https://recallregister.com/fda/iii/93902/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
- What quantity of product is in FDA event 93902?
- The event has 3 product records. The first record gives this quantity:
16 kits
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 2% of the 970 device events that started in 2024 are in Class III.