FDA Device recall Z-0273-2018
VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD
- FDA Device
- Class II
- terminated
- Published 2018-01-03
On 2018-01-03 the FDA classified a Class II recall of VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD by Ortho Clinical Diagnostics, citing the firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for U….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0273-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-12 |
| Published | 2018-01-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | PR |
Product
VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Reason
The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay Summary Chart state serum, heparin plasma, and citrate plasma as acceptable specimen types for use with the PHYT assay.
Identifiers
| code_info | Unique Identifier Number ( UDI) 10758750004690; This issue affects expired, current (in date) and future product GENs. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0273-2018%22
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