In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PT
Summary
The FDA issued a Class III for In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Pr by Abbott Molecular, Inc.. Reason: Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customer.
Details
Source
Device Recall
External ID
Z-1189-2024
Action Date
2024-03-06
Status
Ongoing
Category
device
Product Description
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;
Lot/Code Info: (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.
Quantity Affected: 7 kits
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.
Distribution
US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-01
Company
Des Plaines, IL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 205 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott Molecular, Inc. has 39 FDA actions in our database, including 30 recalls and 9 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Molecular, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Molecular, Inc. have FDA actions?
Abbott Molecular, Inc. has 39 FDA actions in our database, including 30 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1189-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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