Date Initiated by Firm | June 16, 2009 |
Date Posted | March 08, 2010 |
Recall Status1 |
Terminated 3 on November 30, 2010 |
Recall Number | Z-1017-2010 |
Recall Event ID |
52958 |
510(K)Number | K051087 |
Product Classification |
in vitro diagnostic - Product Code JJE
|
Product | Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic. |
Code Information |
Lot number 09061AA exp 2010-03-02 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, Mailstop 514 PO BOX 6101 Newark DE 19714-6101
|
For Additional Information Contact | Customer Service Center 800-241-0420 |
Manufacturer Reason for Recall | Incorrect result: patient sample BUN results reported may be higher or lower than actual level. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Siemens issued an Urgent Field Safety Notice dated 6/16/09 to all affected customers instructing them to discontinue use of the Dimension Vista BUN Flex reagent cartridge lot 09061AA. |
Quantity in Commerce | 1254 cartons |
Distribution | Worldwide distribution: USA, Australia, Canada, Germany, Japan, and Korea. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JJE
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