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FDA (Device enforcement)Recalled 2019-09-10closedclass ii

Ortho-Clinical Diagnostics: VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

Is my product affected?

VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

  • UPC 401006613389
  • UPC 401006613500
  • UPC 401006613501
  • UPC 401006613608
  • UPC 401006613609
  • UPC 401006613648
  • UPC 401006613671
  • UPC 401006613712
  • UPC 401006613796
  • UPC 401006613843
  • UPC 401006613890
  • UPC 401006584017
  • UPC 401006614028
  • UPC 401006584103
  • UPC 401006584161
  • UPC 401006584214
  • UPC 401006584259
  • UPC 401006584230
  • UPC 401006644380
  • UPC 401006644436
  • UPC 401006644502
  • UPC 401006644529
  • UPC 401006644574
  • UPC 401006584374
  • UPC 401006644604
  • UPC 401006644649
  • UPC 401006644670
  • UPC 401006644705
  • UPC 401006644745
  • UPC 401006644800
  • UPC 401006644871
  • UPC 401006644893
  • UPC 401006644896
  • UPC 401006664973
  • UPC 401006665040
  • UPC 401006665041
  • UPC 401006665223
  • UPC 401006665225
  • UPC 401006665226
  • UPC 401006665248

Check against the official notice below — it lists the full affected range.

What happened

Ortho-Clinical Diagnostics is recalling VITROS chemistry Products Cl- Slides (Catalog No. 6844471) used for urine chloride testing. Some cartridges in this recall may experience intermittent problems dispensing slides because an internal component called the anti-backup platen is failing to advance properly. A total of 1,365,545 cartridges are affected. These products were distributed nationwide in the United States and internationally 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 the United Kingdom.

Consumers who use these products can identify affected cartridges by checking their lot codes against the extensive list provided in the recall notice. The recall record does not specify a remedy or corrective action that consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: 401006613389 401006613500 401006613501 401006613608 401006613609 401006613648 401006613671 401006613712 401006613796 401006613843 401006613890 401006584017 401006614028 401006584103 401006584161 401006584214 401006584259 401006584230 401006644380 401006644436 401006644502 401006644529 401006644574 401006584374 401006644604 401006644649 401006644670 401006644705 401006644745 401006644800 401006644871 401006644893 401006644896 401006664973 401006665040 401006665041 401006665223 401006665225 401006665226 401006665248 401006665295 401006665227 401006665228 401006665229 401006665306 401006675376 401006675473 401006675474 401006675513 401006675514 401006675559 401006675477 401006675478 401006675501 401006675552 401006675553 401006675630 401006675631 401006675659 401006675660 401006675803 401006695852 401006695862 401006695908 401006695916 401006675801 401006675802 401006695945 401006676062 401006676063 401006696041 401006696057 401006696079 401006696093 401006767884 401006767998 401006767999 401006768049 401006767969 401006768082 401006767882 401006768133 401006767904 401006767905 401006768134 401006768149 401006768150 401006768183 401006778247 401006778277 401006778340 401006778357 401006778358 401006778470 401006798465 401006798466 401006778505 401006778559 401006778575 401006778593 401006798664 401006798665 401006798696 401006798730 401006798697 401006798835 401006798855 401006798920 401006798997 401006798998 401006799028 401006799092 401006799093 401006799138 401006799171 40100

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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