Recall Z-0740-2020— Ortho Clinical Diagnostics Inc
Class II · Terminated
Class II FDA medical device recall by Ortho Clinical Diagnostics Inc, initiated 2019-10-14, terminated 2020-11-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Ortho Clinical Diagnostics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-14
- Terminated
- 2020-11-13
- Firm location
- Raritan, NJ, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.