Recall Z-2481-2020— Ortho Clinical Diagnostics

Name: FDA recall Z-2481-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-20

Class II · Terminated

Class II FDA medical device recall by Ortho Clinical Diagnostics, initiated 2020-05-20, terminated 2022-11-16. It names one FDA 510(k) clearance: K083173. Product: VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103. Reason: Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances.

Recalling firm: Ortho Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2020-05-20
Terminated: 2022-11-16
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K083173 — VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEMOrtho-Clinical Diagnostics·cleared 2008-12-22

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 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103

Reason for recall

Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances

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