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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products Na Slides

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  Class 2 Device Recall VITROS Chemistry Products Na Slides see related information
Date Initiated by Firm May 05, 2018
Create Date September 28, 2018
Recall Status1 Terminated 3 on February 19, 2021
Recall Number Z-3280-2018
Recall Event ID 80436
510(K)Number K924471  
Product Classification Electrode, ion specific, sodium - Product Code JGS
Product VITROS Sodium Slides, Catalog # 837 9034
Code Information UDI - 10758750004812 GENs- 8, 13, 14, 16, 17 & 18 Expiry Dates: 01-Nov-2018 through 01-Nov-2019
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
513 Technology Blvd
Rochester NY 14626-3601
For Additional Information Contact
585-453-4224
Manufacturer Reason
for Recall		 Potential for positively biased results
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 05 May 2018, Customer letter (Ref. CL2018-123) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all VITROS customers, who have a analyzer capable of running VITROS Na+ slides, to inform them of the issue and to request that they immediately discontinue use of this VITROS Na+ Slides, GENs 8 and 13. Continued use of VITROS Na+ Slides, GENs14,16,17& 18 is acceptable provided the conditions detailed in the communication are met. Foreign affiliates were initially informed by email on 05 May 2018 of the issue and instructed to notify their consignees of the affected product with this issue and the requirement to immediately discontinue use of the VITROS Na+ slides GENs 8, 13, 14, 16, 17 and 18. Due to the amount of time required to ship replacement product to some worldwide locations, a revised communication to the foreign affiliates occurred on 08 June 2018. Due to the health risk associated with potentially leaving the laboratory without a Na+ method, the revised letter instructs customers that they may continue to use GENs 14, 16, 17 and 18 until replacement product is received.
Distribution US Nationwide, Bermuda, Austria, Brazil, Canada, Colombia, China, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium and the Netherlands
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 = JGS and Original Applicant = EASTMAN KODAK COMPANY
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