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
FDA Recall Z-0652-2017 · Posted None
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJIX
Date Initiated2016-09-15
Date Terminated2018-05-31
Product Quantity9,935 units
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.
Firm Action
Siemens mailed an Urgent Medical Device recall notification letter on September 19, 2016 to notify affected customers who purchased the product and to make them aware of the potential risk to health and the actions to be taken. For questions regarding tis recall. For questions regarding this recall call 1-800-441-9250.
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.