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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Urine Electrolyte Diluent

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  Class 2 Device Recall VITROS Urine Electrolyte Diluent see related information
Date Initiated by Firm October 14, 2019
Create Date December 26, 2019
Recall Status1 Terminated 3 on November 13, 2020
Recall Number Z-0740-2020
Recall Event ID 84123
Product Classification Media, potentiating for in vitro diagnostic use - Product Code KSG
Product Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
Code Information Lot with Expiry Date:  V6391 2020-02-26 W6895 2020-09-20 X7127 2021-01-17 Y7593 2021-08-28
Recalling Firm/
Manufacturer		 Ortho Clinical Diagnostics Inc
1001 US Highway 202
Raritan NJ 08869-1424
For Additional Information Contact Joe Falvo
585-453-3452
Manufacturer Reason
for Recall		 Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days.
FDA Determined
Cause 2		 Device Design
Action On August 9, 2019 the firm distributed Urgent Medical Device Recall Communication letters by via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) summarizing the reason as Ortho Clinical Diagnostics determined that VITROS 7% BSA and VITROS Urine Electrolyte Diluent (UED) do not meet the current OAS time of d 7 days when stored on the VITROS 250/350 System in a 2mL cup only. Orthos internal testing compared results from samples diluted with diluent stored on the analyzer versus fresh diluent. When using 7% BSA or UED stored in a 2mL cup for 7 days, the differences in the results vs fresh diluent were >10% for some assays. It explained as a resolution: " The OAS of 7% BSA and UED in 2mL cups has been revised to d24 hours. " Current OAS time remains at d7 days for storage in 5mL and 10 mL bottles. " The Instructions for Use and appropriate User Documentation will be revised at a future date. It instructs them to: - Send the enclosed customer letter to all customers to whom you shipped or know to have a VITROS 250/350 System. Please continue to provide this letter to new customers until the Instructions for Use are updated. - Complete and return the Confirmation of Receipt form by October 22, 2019.
Quantity in Commerce 2,573
Distribution Worldwide distribution - US Nationwide distribution and countries BM, AU, BR, CA, CL, CN, CO, IN, JP, MX, SG, GB, FR, DE, IT, ES, PT, PL, RU, DK, NO, SE, BE, NL.
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.
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