Class 2 Device Recall VITROS

• Date Initiated by Firm: September 10, 2019
• Create Date: November 01, 2019
• Recall Status: Terminated on November 13, 2020
• Recall Number: Z-0267-2020
• Recall Event ID: 83879
• 510(K)Number: K071801 K162020
• Product Classification: Electrode, ion-specific, chloride - Product Code CGZ
• Product: VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
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• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 513 Technology Blvd; Rochester NY 14626-3601
• For Additional Information Contact: Ortho Care Technical Solutions; 585-453-4224
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CGZ and Original Applicant = Ortho Clinical Diagnostics; 510(K)s with Product Code = CGZ and Original Applicant = Ortho-Clinical Diagnostics, Inc.