Recall Z-0848-2015— Ortho-Clinical Diagnostics

Name: FDA recall Z-0848-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-06

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2014-11-06, terminated 2017-02-28. It names one FDA 510(k) clearance: K812029. Product: VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.. Reason: Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2014-11-06
Terminated: 2017-02-28
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K812029 — KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG)Eastman Kodak Company·cleared 1981-08-03

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 CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Reason for recall

Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.

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