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Recall Observatory FDA recall evidence

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

October 10, 2012

Class III

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
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

    reason.no_named_rule · v1.0.0

    Correlation slope bias and accuracy shift