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Recall Observatory FDA recall evidence

Device product

VITROS Chemistry Products COCM Reagent

Z-0817-2014

October 04, 2013

Class II

Product summary

Firm
Ortho-Clinical Diagnostics
Event
Event 66474
Status
Terminated
Classification
Class II
Quantity
3,342 units
Official record key
device-enforcement:Z-0817-2014

Official wording

Reason: Inaccurate quality control results.

Code information: Product Code: 6801995; Lot numbers: 1) 1525-09-2754 Exp Date: 1 Nov 2013, 2) 1525-10-2091 Exp Date: 1 March 2014, 3) 1525-10-3062; Exp Date: 1 April 2014

Distribution pattern: Worldwide Distribution. US nationwide (including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico), Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Inaccurate quality control results.