Ortho Clinical Diagnostics Inc: Medical Device Recall in 2020 - (Recall #: Z-0740-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 14, 2019

Date Posted: January 1, 2020

Recall Number: Z-0740-2020

Event ID: 84123

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.

Status: Terminated

Product Quantity: 2,573

Code Information:

Lot with Expiry Date: V6391 2020-02-26 W6895 2020-09-20 X7127 2021-01-17 Y7593 2021-08-28

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated