Dimension Vista Chemistry 2 Calibrator, Catalog number KC120. Used to calibrate Phosphate, Salicylate, and Triglycerides methods on the Dimension Vista system.
FDA Recall Z-2387-2010 · Posted 2010-09-09
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJIX
Date Initiated2010-02-26
Date Terminated2010-10-13
Product Quantity1310 cartons
Reason for Recall
There is incorrect barcode information, which can potentially cause the Alert Message "Calibrator Insert Missing" to be displayed.
Firm Action
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.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution -- USA, Austria, Germany, Netherlands, Italy, France, Denmark, Portugal, Canada, South Korea, Malaysia, Australia, and New Zealand.
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.
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