Severity
Low
LowClass IIITerminated
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-0864-2017) was formally reported on December 28, 2016, with the manufacturer initiating the action on October 26, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Ortho-Clinical Diagnostics is listed as the recalling firm, operating out of Rochester, NY. Federal records list the affected scope as 124,063 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: 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 CR… Distribution data in the federal record shows the product reached: 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, V…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
124,063 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ortho-Clinical Diagnostics. Units affected: 124,063 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2016. Severity: Low. Recall number: Z-0864-2017.
Where was the recalled product distributed? ▼
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, France, Germany, Italy, Spain and Poland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0864-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 28, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.