—#94324

Product

Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.

FDA product code: CEM — Electrode, Ion Specific, Potassium
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K051087
Affected lot / code info: KA0C03 EXP 3/24/11, KA0D01 EXP 4/14/11, KA0E01 EXP 5/5/11, KA0E02 EXP 5/19/11, KA0F01 EXP 6/3/11, AND KA0G01 EXP 7/8/11

Why it was recalled

High potassium content in the affected lots results in the potential for low potassium recovery for Dilution Check, QC and patient samples when run on the Dimension Vista System.

Root cause (FDA determination)

Other

Action the firm took

Siemens sent an Urgent Field Safety Notice (dated "August 2010") to customers identifying the product, the problem and the action to be taken. Customers were instructed on how to continue testing until new lots of the recalled product were available and asked to complete and fax a Field Correction Effectiveness Check to 301-631-8467 to confirm receipt of the Urgent Field Safety Notice. For technical questions or concerns customers were instructed to contact the Siemens Technical Solutions Center at 800-441-9250.

Recalling firm

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

Distribution

Distribution pattern: USA, Nationwide Distribution

Timeline

Recall initiated: 2010-08-19
Posted by FDA: 2010-10-25
Terminated: 2010-10-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94324. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.