medical Class II Updated 2020-01-01

Ortho Clinical Diagnostics Inc recalls Urine Electrolyte Diluent, Product Code: 1112352 - Product U

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot with Expiry Date: V6391 2020-02-26 W6895 2020-09-20 X7127 2021-01-17 Y7593 2021-08-28
View official government recall

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