—#129484

Product

Siemens Dimension Vista CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), 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: lot 3GM081, exp. 07-01-2014

Why it was recalled

Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081. Investigation by Siemens confirms that QC and patient samples under-recovers MG by 0.25 mg/dL [0.10 mmol/L] across the assay range following calibration with 3GM081.

Root cause (FDA determination)

Process design

Action the firm took

Siemens sent an Urgent Medical Device Dorrection letter, dated August 2014, to all affected consignees. The letter identified the product, the problem, and the actions to be taken. Consignees were instructed if they still have an active calibration of MG with this lot of CHEM 1 CAL, they should immediately calibrate MG with an alternate lot of CHEM 1 CAL. Consigness were instructed to retain the letter with their laboratory records, and to forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Customer Care Center - Techhnical Solutions or their local Siemens technical support representative.

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 - USA (Nationwide) and Internationally to Australia Austria Belgium Canada Czech Republic Finland France Germany Great Britain Italy Japan Netherlands New Zealand Norway Portugal Slovak Republic Slovenia South Korea Spain Switzerland

Timeline

Recall initiated: 2014-08-18
Posted by FDA: 2014-09-30
Terminated: 2015-02-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129484. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.