Reported Mar 6, 2024 · Ongoing
In-vitro diagnostic kits
Abbott Molecular, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Molecular, Inc. · 1300 E Touhy Ave · Des Plaines, IL · 60018-3315
Is this the product you have?
In-vitro diagnostic kits
5 of 5 products
| Model / number | Product as published |
|---|---|
01N33-020 | (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe |
04N62-020 | (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit |
05J03-001 | (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe |
05J03-004 | (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe |
05J04-022 | (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe |
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Product as published 00884999000759(1) REF 01N33-020 - , Lot #381411, Exp. 2024-09-22 00884999009301(2) REF 04N62-020 - , Lot #382133, Exp. 2024-05-25 00884999009882(3) REF 05J03-001 - , Lot #381111, Exp. 2024-06-17 00884999009912(4) REF 05J03-004 - , Lot #381102, Exp. 2024-06-17 00884999010451(5) REF 05J04-022 - , Lot #530242, Exp. 2024-03-28. - Amount recalled
- 7 kits
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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