VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the… — Class II medical device recall Z-1818-2024

Ongoing recall by QUIDELORTHO, reported 2024-05-22, distributed nationwide. T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality c

Recall number	`Z-1818-2024`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	QUIDELORTHO, Rochester, NY, United States
Recall initiated	2024-04-09
Classified	2024-05-14
Reported by FDA	2024-05-22
Distributed	Nationwide (US)
Countries outside the US	AU, BE, BM, BR, CA, CL, CN, CO, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PT, RU, SE, SG
Quantity	21,268 units
UPC / GTIN / UDI-DI	`10758750008797`
Lot numbers	`3042`, `3052`, `3061`, `3080`, `3090`, `3100`, `3110`, `3126`
Expiration dates	`2024-04-09`, `2024-05-02`, `2024-06-06`, `2024-06-14`, `2024-07-29`, `2024-08-13`, `2024-09-04`

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1818-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.