VITROS Chemistry Products PHBR — Class II medical device recall Z-1152-2013
Terminated recall by Ortho-Clinical Diagnostics, reported 2013-05-01, distributed nationwide. Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts
| Recall number | Z-1152-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2013-03-14 |
| Classified | 2013-04-19 |
| Reported by FDA | 2013-05-01 |
| Terminated | 2015-06-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BM, BR, CA, CL, CN, CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, SG, VE |
| Model numbers | 1384, 822 |
Product
VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
Reason for recall
Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD's investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
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-1152-2013. 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.