Reported Nov 13, 2019 · Terminated

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

Ortho-Clinical Diagnostics

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ortho-Clinical Diagnostics · 513 Technology Blvd · Rochester, NY · 14626-3601

Is this the product you have?

  • VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
Lot codes and dates
    • 400506564305
    • 400506564331
    • 400506565287
    • 400506575299
    • 400506575361
    • 400506635353
    • 400506758400
    • 400506728360
    • 400506788811
    • 400506758797
    • 400506758798
    • 400506789422
    • 400506789423
    • 400506809507
    • 400506809508
    • 400506820116
    • 400506895392
    • 400506895393
    • 400506895394
Amount recalled
1365545 total

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 13, 2020 · Data as of Sep 19, 4:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.