FDAClass IINovember 13, 2019

VITROS chemistry Products Cl- Slides recall

VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry…

Why was VITROS chemistry Products Cl- Slides recalled?

Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry…
Recalling firm
Ortho-Clinical Diagnostics
Quantity
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.
Recall date
November 13, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls