—#89091

Product

Dimension Vista Chemistry 2 Calibrator, Catalog number KC120. Used to calibrate Phosphate, Salicylate, and Triglycerides 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: K061703
Affected lot / code info: Lot number 9GM001 exp 7/2010

Why it was recalled

There is incorrect barcode information, which can potentially cause the Alert Message "Calibrator Insert Missing" to be displayed.

Root cause (FDA determination)

Employee error

Action the firm took

The recalling firm issued an Urgent field Safety Notice, dated February 2010, to all affected customers informing them of the problem. Customers have been told to run calibrators from cups when calibrating or request a replacement lot. The notification should be forwarded to that this product was further distributed to. Siemens Technical Solutions Center should be contacted at 800-441-9250, if they are any technical questions.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: Worldwide Distribution -- USA, Austria, Germany, Netherlands, Italy, France, Denmark, Portugal, Canada, South Korea, Malaysia, Australia, and New Zealand.

Timeline

Recall initiated: 2010-02-26
Posted by FDA: 2010-09-09
Terminated: 2010-10-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89091. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.