Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0652-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista¿ System

Product Classification:

Class II

Date Initiated: September 15, 2016

Date Posted: November 30, 2016

Recall Number: Z-0652-2017

Event ID: 75484

Reason for Recall:

Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista¿ CHEM 1 CAL lots 5GM081 and 5GM082.

Status: Terminated

Product Quantity: 9,935 units

Code Information:

Device Listing Number: D011448 (Kc110) and D244577 (KC110B) Lot numbers: MGM081 and MGM082

Distribution Pattern:

Worldwide Distribution - US (Nationwide) Internationally to Australia, Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Italy, Japan, Netherlands, New Zealand, Norway, Portugal, Qatar, Saudi Arabia, South Korea, Slovakia, Slovenia, Spain, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated