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U.S. Department of Health and Human Services

Class 3 Device Recall Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine

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  Class 3 Device Recall Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine see related information
Date Initiated by Firm November 21, 2012
Date Posted January 04, 2013
Recall Status1 Terminated 3 on November 06, 2014
Recall Number Z-0636-2013
Recall Event ID 63809
510(K)Number K943780  
Product Classification Urinalysis controls (assayed and unassayed) - Product Code JJW
Product Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine
Chemistry
Catalog Number: 5019

When used with the CLINITEK ATLAS¿ Automated urine Chemistry Analyzer and CLINITEK ATLAS¿ 10 reagent Pak, CLINITEK ATLAS¿ Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas.
Code Information Carton/Bottle Lot Number: S9093061A P9093061A  S9094081A P9094081A  S0097091C P0097091C  S9093061A P9093061A S9094081A P9094081A  S0097091C P0097091C  S0100101B P0100101B  S0103042A P0103042A  S0103042H P0103042H  S0106062A P0106062A  S9101022A P9101022A  S9101022B P9101022B  S9105052A P9105052A 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
For Additional Information Contact Mark Smith
781-269-3158
Manufacturer Reason
for Recall		 When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens issued An Urgent Field Safety Notice via e-mail to all affected SiemensHealthcare Diagnostics Regional offices on November 21, 2012 both in the United States and foreign accounts. This notice informed customers of the issue with the CLINITEK Atlas¿ and Chek-Stix¿ Positive Urinalysis Control Solutions When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F). You can use the reconstituted positive control solution for up to eight hours if the solution is held at 25¿C (77¿F) or lower. If the operating temperature is greater than 25¿C and lower than 30¿C (77¿F and 86¿F), the solution can be used for up to two hours. For questions regarding this recall call 781-269-3158.
Quantity in Commerce 6466
Distribution Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
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 = JJW and Original Applicant = HERAEUS KULZER, INC.
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