—#176664

Product

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

FDA product code: CGZ — Electrode, Ion-Specific, Chloride
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K071801
Affected lot / code info: 400506564305 400506564331 400506565287 400506575299 400506575361 400506635353 400506758400 400506728360 400506788811 400506758797 400506758798 400506789422 400506789423 400506809507 400506809508 400506820116 400506895392 400506895393 400506895394

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.

Root cause (FDA determination)

Process control

Action the firm took

On September 10, 2019, the firm distributed Urgent Product Correction Notification letters to affected customers. Customers were asked to take the following actions: "Complete and return the Confirmation of Receipt form. "If you experience a slide dispense issue, try to reposition the ABP by following the instructions in the enclosed Resolving Slide Dispense Issues document. Please place the instructions by each VITROS System in your facility that processes Microslides. "If you are unable to reposition the ABP, remove the affected cartridge and replace it with a new one. Complete and return the Request for Credit form as needed to receive credit for the slides remaining within affected and discarded cartridges. "Please forward this notification if the product was distributed outside of your facility. The firm will provide credit for the slides remaining within affected cartridge for which you are unable to reposition the ABP. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 513 Technology Blvd, Rochester, New York 14626-3601

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-09-10
Terminated: 2020-11-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176664. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.