VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (
Summary
The FDA issued a Class II for VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitativ by QUIDELORTHO. Reason: T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may ca.
Details
Source
Device Recall
External ID
Z-1818-2024
Action Date
2024-05-22
Status
Ongoing
Category
device
Product Description
VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 131 5589
Lot/Code Info: UDI-DI: 10758750008797 Lot Numbers: 3042 Expiry: 09-Apr-2024; 3052 Expiry: 02-May-2024; 3061 Expiry: 06-Jun-2024; 3080 Expiry: 02-May-2024; 3090 Expiry: 14-Jun-2024; 3100 Expiry: 29-Jul-2024; 3110 Expiry: 13-Aug-2024; 3126 Expiry: 04-Sep-2024
Quantity Affected: 21268 units
Reason for Recall
T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of other thyroid function tests.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore , Spain, Sweden, The Netherlands, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-09
Company
Rochester, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
QUIDELORTHO has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (QUIDELORTHO) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does QUIDELORTHO have FDA actions?
QUIDELORTHO has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1818-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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