CLASS II Device recall · Reported 22 Mar 2017 · FDA Enforcement Report
Vitros Chemistry Products Li (Lithium) Slides recalled
Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products Li (Lithium) Slides, distributed in Puerto Rico. The recall was initiated on 1 Feb 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1471-2017
- FDA event ID
- 76438
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Feb 2017
- FDA classified
- 15 Mar 2017
- Reported
- 22 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 1 Feb 2017 | Recall initiated by company | |
| 15 Mar 2017 | Classified by FDA | +42 days |
| 22 Mar 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
US, Puerto Rico, Canada, EU, China, Brazil, Chile, and Dominican Republic.
Questions about this recall
Why was it recalled?
Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.
Which lots are affected?
REF/Product Code 1632660: Lot 3124-0108-6568, exp. 2018- 04-01; REF/Product Code 8318925: Lot 3124-0108-6569, exp. 2018- 05-01
Where was it sold?
US, Puerto Rico, Canada, EU, China, Brazil, Chile, and Dominican Republic.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ortho-Clinical Diagnostics
All 311| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products LAC Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
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