VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics has recalled VITROS chemistry Cl- Slides (Catalog No. 8445207) used in clinical laboratory testing. The recalled product is a MicroSlide containing reagents in dry, multi-layered form. The recall affects 1,365,545 total units distributed nationwide in the United States and internationally to 24 countries including Canada, Japan, Germany, and the United Kingdom. Specific lot numbers are identified in the recall notice.
The issue with the recalled slides is that users may experience intermittent problems with slide dispensing from some cartridges due to a component called the anti-backup platen failing to advance properly inside the cartridge. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
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. Quantity: 1365545 total Lot/code info: 400506564305 400506564331 400506565287 400506575299 400506575361 400506635353 400506758400 400506728360 400506788811 400506758797 400506758798 400506789422 400506789423 400506809507 400506809508 400506820116 400506895392 400506895393 400506895394
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.