Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 22, 2017
VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720, RX ONLY, IVD --Ortho Clinical Diagnostics, Inc. Rochester, NY 14626 --- Background: The VITROS Li Slide is a multilayered, analytical element coated on a polyester support. During the coating process, thin layers of re
Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ortho-Clinical Diagnostics recalled VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (1… - a moderate-severity action.
VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (1… was recalled by Ortho-Clinical Diagnostics in March 22, 2017. Reason: Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.. Check the official notice for the remedy. Verify recall #Z-1471-2017 with the FDA Devices before acting.
The recall
Ortho-Clinical Diagnostics issued this moderate-severity FDA Devices recall-Intermittent imprecision in results generated using two specific lots of VITROS Li Slides..
- Moderate
- severity level
- Class II
- classification
- March 22, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1471-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1471-2017) was formally reported on March 22, 2017, with the manufacturer initiating the action on February 1, 2017. 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 US: 94 sales units; OUS: 136 sales units.
The documented reason for this recall is: Intermittent imprecision in results generated using two specific lots of VITROS Li Slides. Distribution data in the federal record shows the product reached: US, Puerto Rico, Canada, EU, China, Brazil, Chile, and Dominican Republic.. 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
US: 94 sales units; OUS: 136 sales units
Related Recalls
6
3 from same agency
Product description
VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720, RX ONLY, IVD --Ortho Clinical Diagnostics, Inc. Rochester, NY 14626 --- Background: The VITROS Li Slide is a multilayered, analytical element coated on a polyester support. During the coating process, thin layers of reagents are coated onto a polyester support layer to create a spreading layer and a chemical (reagent) layer. During the coating process rolls of materials are produced. These rolls are segmented into slits. There are several slits in each roll. Each slit is then cut into small chemistry chips that are positioned between plastic to create the final Microslide format. Eighteen (18) or sixty (60) slides are placed into each plastic cartridge for use. Each slide is a device.
Reason for recall
Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1471-2017 |
| Date reported | March 22, 2017 |
| Date initiated | February 1, 2017 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Firm location | Rochester, NY |
| Affected scope | US: 94 sales units; OUS: 136 sales units |
| Distribution | US, Puerto Rico, Canada, EU, China, Brazil, Chile, and Dominican Republic. |
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-1471-2017) 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 Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720, RX ONLY, IVD --Ortho Clinical Diagnostics, Inc. Rochester, NY 14626 --- Background: The VITROS Li Slide is a multilayered, analytical element coated on a polyester support. During the coating process, thin layers of reagents are coated onto a polyester support layer to create a spreading layer and a chemical (reagent) layer. During the coating process rolls of materials are produced. These rolls are segmented into slits. There are several slits in each roll. Each slit is then cut into small chemistry chips that are positioned between plastic to create the final Microslide format. Eighteen (18) or sixty (60) slides are placed into each plastic cartridge for use. Each slide is a device.. Recalled by Ortho-Clinical Diagnostics. Units affected: US: 94 sales units; OUS: 136 sales units.
Why was this product recalled? ▼
Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 22, 2017. Severity: Moderate. Recall number: Z-1471-2017.
Where was the recalled product distributed? ▼
Distribution: US, Puerto Rico, Canada, EU, China, Brazil, Chile, and Dominican Republic..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1471-2017) 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 March 22, 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.