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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS

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  Class 2 Device Recall VITROS see related information
Date Initiated by Firm September 10, 2019
Create Date November 01, 2019
Recall Status1 Terminated 3 on November 13, 2020
Recall Number Z-0268-2020
Recall Event ID 83879
510(K)Number K071801  
Product Classification Electrode, ion-specific, chloride - Product Code CGZ
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.
Code Information 400506564305 400506564331 400506565287 400506575299 400506575361 400506635353 400506758400 400506728360 400506788811 400506758797 400506758798 400506789422 400506789423 400506809507 400506809508 400506820116 400506895392 400506895393 400506895394 
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 2		 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, Inc.
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