—#150478

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

FDA product code: JIX — Calibrator, Multi-Analyte Mixture
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K061838
Affected lot / code info: Device Listing Number: D011448 (Kc110) and D244577 (KC110B) Lot numbers: MGM081 and MGM082

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

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.

Timeline

Recall initiated: 2016-09-15
Terminated: 2018-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150478. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.