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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-0269-2020
Recall Event ID 83879
510(K)Number K073157  
Product Classification Electrode, ion specific, potassium - Product Code CEM
Product VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
Code Information 410209876551 410209876548 410209876539 410209950186 410209950196 410209950232 410209960354 410209960373 410209960330 410209960477 410209960495 410209970685 410209970716 410209970763 410209960548 410209960590 410209960591 410209960625 410209960626 410209970818 410209971322 410209971446 410209971447 410209971483 410209971484 410209971485 410209971602 410209971699 410209981652 410209981767 410209991938 410209991939 410210003291 410210003396 410210003507 410210003510 410210023496 410210023498 410210003645 410210003669 410210003719 410210003775 410210013798 410210013912 410210013938 410210013966 410210013996 410210014061 410210014053 410210024095 410210014134 410210024167 410210024196 410210024284 410210024342 410210024403 410210024438 410210024469 410210024506 410210044598 410210054742 410210044699 410210044700 410210044751 410210044842 410210045037 410210045051 410210045095 410210045097 410210045186 410210055198 410210055249 410210055278 410210085927 410210085928 410210085986 410210086101 410210086109 410210086142 410210086198 410210086287 410210086304 410210096368 410210096494 410210096478 410210096588 410210096658 410210096686 410210096701 410210096723 410210066822 410210066936 410210066947 410210066992 410210067044 410210067073 410210067109 410210067201 410210067205 410210067287 410210067304 410210107327 410210137302 410210107400 410210107489 410210107514 410210107551 410210107603 410210107673 410210107674 410210127698 410210127910 410210127985 410210127978 410210128212 410210138441 410210138469 410210138500 410210148567 410210148628 410210148716 410210148756 410210149025 410210149031 410210149051 410210149085 410210149117 410210149118 410210159091 410210159112 410210159179 410210159232 410210159262 410210159277 410210169332 410210169337 410210169383 410210169384 410210169431 410210169485 410210189482 410210169504 410210169548 410210169628 410210169681 410210169705 410210169775 410210169822 410210169840 410210179951 410210169870 410210179976 410210179986 410210170029 410210160143 410210180175 410210190174 410210180214 410210180297 410210180349 410210180374 410210180376 410210180454 410210200457 410210180492 410210180493 410210180632 410210190649 410210180652 410210180686 410210190676 410210190808 410210190828 410210190892 
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 = CEM and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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