Device product
VITROS Chemistry Products COCM Reagent
Z-0817-2014
Product summary
- 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
Inaccurate quality control results.