| Class 2 Device Recall VITROS Urine Electrolyte Diluent | |
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
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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
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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 |
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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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