Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0988-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: October 10, 2012

Date Posted: April 3, 2013

Recall Number: Z-0988-2013

Event ID: 63494

Reason for Recall:

Correlation slope bias and accuracy shift

Status: Terminated

Product Quantity: 1985 cartons

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.

Voluntary or Mandated:

Voluntary: Firm initiated