VITROS Immunodiagnostic Products TSH Reagent Pack — Class III medical device recall Z-1322-2018
Terminated recall by Clinical Diagnostic Systems, reported 2018-04-18. VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some cu
| Recall number | Z-1322-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clinical Diagnostic Systems, Rochester, NY, United States |
| Recall initiated | 2018-01-11 |
| Classified | 2018-04-11 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2020-09-08 |
| Lot numbers | 5178, 5430, 5470 |
| Expiration dates | 2018-03-01, 2018-05-24 |
Product
VITROS Immunodiagnostic Products TSH Reagent Pack
Reason for recall
VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.
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-1322-2018. 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.