Ortho Clinical Diagnostics Inc: Medical Device Recall in 2020 - (Recall #: Z-0739-2020)

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:

7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

Product Classification:

Class II

Date Initiated: October 14, 2019

Date Posted: January 1, 2020

Recall Number: Z-0739-2020

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: 16,584

Code Information:

Lot with Expiry Date: D6289 2019-11-20 E6382 2020-01-15 F6602 2020-05-02 G6679 2020-08-13 H6897 2020-10-01 J7129 2021-01-23 K7421 2021-07-01 L7592 2021-08-26

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