FDA Devices recall · Reported December 28, 2016
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
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…
Ortho-Clinical Diagnostics recalled VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit),… - a low-severity action.
VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit),… was recalled by Ortho-Clinical Diagnostics in December 28, 2016. Reason: CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent P…. Check the official notice for the remedy. Verify recall #Z-0864-2017 with the FDA Devices before acting.
The recall
Ortho-Clinical Diagnostics issued this low-severity FDA Devices recall-CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent P….
- Low
- severity level
- 124K units
- affected scope
- Class III
- classification
- December 28, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0864-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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 for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0864-2017 |
| Date reported | December 28, 2016 |
| Date initiated | October 26, 2016 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Firm location | Rochester, NY |
| Affected scope | 124,063 units |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, F… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0864-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026