VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use… — Class II medical device recall Z-1819-2024
Ongoing recall by QUIDELORTHO, reported 2024-05-22, distributed nationwide. Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality c
| Recall number | Z-1819-2024 |
|---|---|
| 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 |
| UPC / GTIN / UDI-DI | 10758750008438 |
| 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 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 111 2820
Reason for recall
Free T3 Calibrators used with T3 Reagent Packs 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-1819-2024. 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.