Recall Z-0080-2019— Ortho-Clinical Diagnostics

Name: FDA recall Z-0080-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-15

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2018-08-15, terminated 2022-01-10. It names one FDA 510(k) clearance: K081543. Product: VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802915. Reason: Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2018-08-15
Terminated: 2022-01-10
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- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802915

Reason for recall

Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.

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