Free T3 Reagent Pack May Produce Inaccurate Test Results
QUIDELORTHO's VITROS Free T3 Reagent Packs may produce falsely elevated test results, potentially affecting thyroid function diagnoses and patient management. Eight lot numbers with expiry dates through August 2024 were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a diagnostic device that may produce inaccurate test results affecting thyroid function assessment and patient clinical management. Although no illnesses or injuries have been reported, the potential for diagnostic error to impact patient care justifies a High severity rating under the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
QUIDELORTHO is recalling VITROS Immunodiagnostic Products Free T3 Reagent Packs (Product Code: 131 5589) due to a reagent defect. The product is used to quantitatively measure free triiodothyronine (FT3) levels in blood serum and plasma.
The recalled reagent packs may produce positively biased (falsely elevated) test results. This positive bias may cause erroneous patient test results, delay in testing, and may impact patient management, clinical assessment of thyroid function, and the results of other thyroid function tests.
The recall affects 21,268 units distributed worldwide, including nationwide in the United States and to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and the United Kingdom. Eight lot numbers are affected, with expiry dates ranging from April 2024 through August 2024: lot numbers 3042, 3052, 3061, 3080, 3090, 3100, 3110, and 3126 (UDI-DI: 10758750008797).
The recalled product
- Product
- 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
- Manufacturer
- QUIDELORTHO
- Affected units
- 21,268
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by QUIDELORTHO under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · QUIDELORTHO
See all →- HighVITROS Free T3 Calibrators recalled due to positive bias in thyroid test results
FDA (Devices) · 2024-05-22
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