FDA Device Recall Z-0139-2011: Siemens Healthcare Diagnostics, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0139-2011.

Recall Res Number

Z-0139-2011

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics, Inc.

FEI Number

2517506

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2010-08-19

Date Posted

2010-10-25

Date Terminated

2010-10-26

Product Code

CEM

Event Number

56703

Product Quantity

3,706 cartons

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

Reason for Recall 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.

Action Details 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.

Distribution Pattern USA, Nationwide Distribution

Code Information / Serial Numbers 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

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Medical Device Recall: Z-0139-2011

Recall Parameters & Description

Related Establishments / Registrations

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