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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 Recall
Siemens Healthcare CLINITEK Status Analyzer
see related information
Date Posted May 04, 2014
Recall Status1 Terminated on May 06, 2014
Recall Number Z-1545-2014
Recall Event ID 67930
Premarket Notification
510(K) Number
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/
Siemens Healthcare Diagnostics Inc
2 Edgewater Drive
Norwood, Massachusetts 02062
Manufacturer Reason
for Recall
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KQO and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS