Z-0268-2020 Class II Terminated

Recalled by Ortho-Clinical Diagnostics — Rochester, NY

Recall Details

Product Type
Devices
Report Date
November 13, 2019
Initiation Date
September 10, 2019
Termination Date
November 13, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1365545 total

Product Description

VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). 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.

Distribution Pattern

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.

Code Information

400506564305 400506564331 400506565287 400506575299 400506575361 400506635353 400506758400 400506728360 400506788811 400506758797 400506758798 400506789422 400506789423 400506809507 400506809508 400506820116 400506895392 400506895393 400506895394