Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0008-2024)

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:

Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)

Product Classification:

Class II

Date Initiated: August 9, 2023

Date Posted: October 11, 2023

Recall Number: Z-0008-2024

Event ID: 92927

Reason for Recall:

Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause VITROS VersaTips and/or VITROS MicroTips to be improperly seated on the proboscis, which may result in falsely elevated Gentamicin and Valproic Acid assay results as well as an increased frequency of condition codes resulting in delayed patient results. The issue was identified by internal testing when reported instruments failed to pass release testing and were traced to the molded Proboscis part J56639 with date codes from 040722 onward.

Status: Ongoing

Product Quantity: 9,860 assemblies

Code Information:

Assemblies with a date code between 040722 - 121922

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated