Recall Z-1226-2024— Ortho-Clinical Diagnostics, Inc.

Name: FDA recall Z-1226-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-26

Class II · Ongoing

Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2024-01-26. It names one FDA 510(k) clearance: K081543. Product: VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished). Reason: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported..

Recalling firm: Ortho-Clinical Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-01-26
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K081543 — VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEMOrtho-Clinical Diagnostics, Inc.·cleared 2008-10-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)

Reason for recall

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

Data sourced from openFDA. This site is unofficial and independent of the FDA.