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Terminated

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.

FDA Recall Z-0090-2017 · Posted None

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeKHP
Date Initiated2016-08-11
Date Terminated2018-06-11
Product QuantityUS: 32,081 sales units; Foreign: 29,932 sales units

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.

Firm Action

Ortho-Clinical Diagnostics sent an URGENT PRODUCT CORRECTION Letter (Ref. CL2016-152) dated August 11, 2016 via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all customers who could order and use affected product to inform them that new interferant were identified for GLU, LAC, TRIG and URIC Slides which may cause biased results. Foreign affiliates were informed by e-mail on August 11, 2016, of the issue and instructed to notify their consignees of the issue. For questions, please contact our Ortho CareTM Technical Solutions Center at 1-800-421-3311. For questions regarding this recall call 908-218-8776.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K955286EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)Johnson & Johnson Clinical Diagnostics, Inc. · 1996-05-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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