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U.S. Department of Health and Human Services

Class 3 Device Recall Siemens ChekStix Combo Pak

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 Class 3 Recall
Siemens ChekStix Combo Pak
see related information
Date Posted January 04, 2013
Recall Status1 Open
Recall Number Z-0639-2013
Recall Event ID 63809
Premarket Notification
510(K) Number
K943780 
Product Classification Urinalysis Controls (Assayed And Unassayed) - Product Code JJW
Product Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Code Information Carton/Bottle Lot Number: CP0099091B P0099091B C0100101G P0100101G C0103042E P0103042E
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood, Massachusetts 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 325
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 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 = JJW and Original Applicant = HERAEUS KULZER, INC.
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