Recall Z-1834-2020— Ortho Clinical Diagnostics

Name: FDA recall Z-1834-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-10

Class III · Terminated

Class III FDA medical device recall by Ortho Clinical Diagnostics, initiated 2020-03-10, terminated 2022-09-26. It names one FDA 510(k) clearance: K160495. Product: VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468. Reason: The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations..

Recalling firm: Ortho Clinical Diagnostics
Classification: Class III
Status: Terminated
Initiated: 2020-03-10
Terminated: 2022-09-26
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K160495 — VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.·cleared 2016-10-18

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 Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468

Reason for recall

The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.

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