VITROS Chemistry Products Calibrator Kit 9 Calibrator — Class III medical device recall Z-0202-2016
Terminated recall by Ortho-Clinical Diagnostics, reported 2015-11-11, distributed nationwide. The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors)
| Recall number | Z-0202-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2015-09-28 |
| Classified | 2015-11-03 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2018-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, CN, CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, SG, VE |
| UPC / GTIN / UDI-DI | 10758750005031 |
| Lot numbers | 0954 |
| Expiration dates | 2016-05-31 |
Product
VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, and PHYT.
Reason for recall
The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.
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-0202-2016. 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.