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Terminated

VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

FDA Recall Z-1087-2014 · Posted 2014-02-25

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeJGS
Date Initiated2013-10-17
Date Terminated2018-05-18
Product Quantity548,663 units

Reason for Recall

Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.

Firm Action

Ortho Clinical Diagnostics sent an Urgent Product Correction Notification dated October 17, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Ortho Clinical Diagnostics recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample. Please forward a copy of the notification letter if the products were further distributed. Complete and return the attached Confirmation of Receipt form by October 25, 2013. Customers with questions please call Customer Technical Service at 1-800-421-3311.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, France, Italy and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081411VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2Ortho-Clinical Diagnostics, Inc. · 2008-06-30K924471KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)Eastman Kodak Company · 1992-11-06

Official Source

View FDA Recall →

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

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