Recall Z-1675-2022— Ortho-Clinical Diagnostics, Inc.

Name: FDA recall Z-1675-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-19

Class II · Ongoing

Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2022-07-19. It names one FDA 510(k) clearance: K182063. Product: VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458. Reason: Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System..

Recalling firm: Ortho-Clinical Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-07-19
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K182063 — VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc.·cleared 2018-10-30

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 XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458

Reason for recall

Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.

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