• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Siemens Healthcare CLINITEK Status Analyzer

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall Siemens Healthcare CLINITEK Status Analyzersee related information
Date Initiated by FirmFebruary 26, 2013
Date PostedMay 04, 2014
Recall Status1 Terminated 3 on May 06, 2014
Recall NumberZ-1545-2014
Recall Event ID 67930
510(K)NumberK091216 
Product Classification Automated urinalysis system - Product Code KQO
ProductCLINITEK 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
ActionOn 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 Commerce1 unit
DistributionUS Distribution in the state of: CA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KQO
-
-