FDA recall Z-0267-2020

Product

VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports 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

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.

Key facts

Status

Terminated

Initiation date

2019-09-10

Report date

2019-11-13

Termination date

2020-11-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0267-2020