In-vitro diagnostic kits recall
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;
Why was In-vitro diagnostic kits 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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.
- Product
- 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;
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- 7 kits
- Distribution
- US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
- Recall date
- March 6, 2024
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)