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.
This recall has been terminated (originally issued October 14, 2019).
- Company
- Ortho Clinical Diagnostics Inc
- Recall Initiated
- October 14, 2019
- Terminated
- November 13, 2020
- Recall Number
- Z-0740-2020
- Quantity
- 2,573
- Firm Location
- Raritan, NJ
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Lot with Expiry Date: V6391 2020-02-26 W6895 2020-09-20 X7127 2021-01-17 Y7593 2021-08-28
Root Cause
Device Design
Action Taken
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.