Device product
Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.
Z-0988-2013
Product summary
- Event
- Event 63494
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1985 cartons
- Official record key
device-enforcement:Z-0988-2013
Official wording
Reason: Correlation slope bias and accuracy shift
Code information: Lot 2AD052 Catolog KC330
Distribution pattern: Nationwide distribution: USA including Puerto Rico and the states of AL, OH, MO, GA, IL, CT, IA, SC, VA, TX, FL, NY, NC, CA, NM, AZ, CA, MI, NJ, PR, MS, NE, WV, PA, MT, MA, MD, KS, NH, TN, VT, LA, CO, ID, WA, NH, DE and OR.
Derived failure modes
-
Unknown
Correlation slope bias and accuracy shift