VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS… — Class II medical device recall Z-1226-2020
Terminated recall by Ortho Clinical Diagnostics Inc, reported 2020-02-19, distributed nationwide. Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator K
| Recall number | Z-1226-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho Clinical Diagnostics Inc, Raritan, NJ, United States |
| Recall initiated | 2019-12-16 |
| Classified | 2020-02-13 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2020-11-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CL, CN, CO, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PL, PT, RU, SE, SG |
| UPC / GTIN / UDI-DI | 10758750009503 |
| Lot numbers | 219, 277, 288, 298 |
Product
VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG Product Code: 1662659
Reason for recall
Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2
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-1226-2020. 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.