Ortho-Clinical Diagnostics: Medical Device Recall in 2019 - (Recall #: Z-2202-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems

Product Classification:

Class II

Date Initiated: June 17, 2019

Date Posted: August 14, 2019

Recall Number: Z-2202-2019

Event ID: 83228

Reason for Recall:

Potentially Biased Results using VITROS Chemistry Products GLU Slides

Status: Terminated

Product Quantity: 1099 (5 pack x 60)=329700 slides

Code Information:

Lot Number:0048-0964-9287; Exp Date:2020-11-01 UDI: 10758750009572

Distribution Pattern:

US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN

Voluntary or Mandated:

Voluntary: Firm initiated