FDA Device recall Z-0864-2017
VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Produ…
- FDA Device
- Class III
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class III recall of VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Produ… by Ortho Clinical Diagnostics, citing CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively bias….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0864-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-10-26 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740
Reason
CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results if the endogenous level of CRP in the diluent is not subtracted from the final result. The IFUs do not provide specific instructions for how to account for endogenous CRP in the diluent when calculating the sample result. Orthos diluents used to dilute samples containing CRP are manufactured using human plasma based fluids that contain endogenous CRP. Without accounting for the CRP in the diluent and removing its contribution from the result, the reported result will include the CRP present in both the sample and diluent, possibly leading to positively biased results.
Identifiers
| code_info | Affected Generations (GENs): 3, 11, 12, 30 through 36 |
|---|
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-0864-2017%22
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