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U.S. Department of Health and Human Services

Class 3 Device Recall Siemens Healthcare CLINITEK Status Analyzer

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  Class 3 Device Recall Siemens Healthcare CLINITEK Status Analyzer see related information
Date Initiated by Firm February 26, 2013
Date Posted May 04, 2014
Recall Status1 Terminated 3 on May 06, 2014
Recall Number Z-1545-2014
Recall Event ID 67930
510(K)Number K091216  
Product Classification Automated urinalysis system - Product Code KQO
Product CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Code Information Serial Number: 212809
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Drive
Norwood MA 02062
For Additional Information Contact
781-269-3000
Manufacturer Reason
for Recall		 Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
FDA Determined
Cause 2		 Reprocessing Controls
Action On February 26, 2013, a Siemens Field Engineer from Siemens Healthcare visited customer site and disabled the Sample Interference Notes feature on the instrument.
Quantity in Commerce 1 unit
Distribution US Distribution in the state of: CA.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = KQO and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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