Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 8, 2017
VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ortho-Clinical Diagnostics recalled VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ S… - a moderate-severity action.
VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ S… was recalled by Ortho-Clinical Diagnostics in February 8, 2017. Reason: There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using …. Check the official notice for the remedy. Verify recall #Z-1117-2017 with the FDA Devices before acting.
The recall
Ortho-Clinical Diagnostics issued this moderate-severity FDA Devices recall-There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using ….
- Moderate
- severity level
- Class II
- classification
- February 8, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1117-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1117-2017) was formally reported on February 8, 2017, with the manufacturer initiating the action on December 20, 2016. It is classified under Moderate severity (Class II), 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 659,957 Total Units (249,570 units domestically & 410,387 units internationally).
The documented reason for this recall is: There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum wa… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Franc…. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
659,957 Total Units (249,570 units domestically & 410,387 units internationally)
Related Recalls
6
3 from same agency
Product description
VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Reason for recall
There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum warm up requirements stated in the IFU. If Quality Control (QC) results are within acceptable limits, reported results are acceptable and were not affected by this issue.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1117-2017 |
| Date reported | February 8, 2017 |
| Date initiated | December 20, 2016 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Firm location | Rochester, NY |
| Affected scope | 659,957 Total Units (249,570 units domestically & 410,387 units internationally) |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, S… |
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-1117-2017) 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 Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.. Recalled by Ortho-Clinical Diagnostics. Units affected: 659,957 Total Units (249,570 units domestically & 410,387 units internationally).
Why was this product recalled? ▼
There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum warm up requirements stated in the IFU. If Quality Control (QC) results are within acceptable limits, reported results are acceptable and were not affected by this issue.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 8, 2017. Severity: Moderate. Recall number: Z-1117-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) Distribution 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-1117-2017) 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 February 8, 2017. 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.