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Recall Observatory FDA recall evidence

Device product

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.

Z-1087-2014

October 17, 2013

Class II

Product summary

Firm
Ortho-Clinical Diagnostics
Event
Event 66774
Status
Terminated
Classification
Class II
Quantity
548,663 units
Official record key
device-enforcement:Z-1087-2014

Official wording

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

Code information: Product Code 8379034; Affected Generations (GENs)/Lots: GENs 7 - 13; Expiry Dates: 2013-11-01 thru 2015-01-01

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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