FDA Devices recall · Reported May 3, 2017
VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system,
Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the o…
Ortho-Clinical Diagnostics recalled VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. … - a moderate-severity action.
VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. … was recalled by Ortho-Clinical Diagnostics in May 3, 2017. Reason: Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after …. Check the official notice for the remedy. Verify recall #Z-1887-2017 with the FDA Devices before acting.
The recall
Ortho-Clinical Diagnostics issued this moderate-severity FDA Devices recall-Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after ….
- Moderate
- severity level
- Class II
- classification
- May 3, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1887-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. 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 moderate 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 Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use.
Reason for recall
Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1887-2017 |
| Date reported | May 3, 2017 |
| Date initiated | February 21, 2017 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Firm location | Rochester, NY |
| Affected scope | US: 2740; OUS: 616 |
| Distribution | Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Spain Singapore and Venezue… |
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-1887-2017) 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 (Moderate), 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