Recall Z-0090-2017— Ortho-Clinical Diagnostics

Name: FDA recall Z-0090-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-11

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2016-08-11, terminated 2018-06-11. It names one FDA 510(k) clearance: K955286. Product: VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier Nos. 10758750004911 and 10758750004454, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.. Reason: Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2016-08-11
Terminated: 2018-06-11
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K955286 — EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)Johnson & Johnson Clinical Diagnostics, Inc.·cleared 1996-05-17

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 LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier Nos. 10758750004911 and 10758750004454, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Reason for recall

Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.

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