VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
Reported: November 13, 2019 Initiated: September 10, 2019 #Z-0269-2020
Product Description
VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
Reason for Recall
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics
- Units Affected
- 1365545 total
- Distribution
- Domestic distribution nationwide. Foreign distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, the Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.. Recalled by Ortho-Clinical Diagnostics. Units affected: 1365545 total.
Why was this product recalled? ▼
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2019. Severity: Moderate. Recall number: Z-0269-2020.
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