Recall Z-0652-2017
Siemens Healthcare Diagnostics, Inc. · initiated September 15, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Device Listing Number: D011448 (Kc110) and D244577 (KC110B) Lot numbers: MGM081 and MGM082
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0652-2017
- Initiated
- September 15, 2016
- Terminated
- May 31, 2018
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Quantity
- 9,935 units
- Distribution
- 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.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE