Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1664-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696

Product Classification:

Class II

Date Initiated: April 14, 2023

Date Posted: June 7, 2023

Recall Number: Z-1664-2023

Event ID: 92245

Reason for Recall:

Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing

Status: Ongoing

Product Quantity: 132 units

Code Information:

UDI-DI: 10758750006601 Lot Number: 1172 Exp. 20-OCT-2023

Distribution Pattern:

Nationwide Foreign: Brazil, Chile, Colombia

Voluntary or Mandated:

Voluntary: Firm initiated