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U.S. Department of Health and Human Services

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 Class 2 Recall
Siemens Chek-Stix Combo Pak 		see related information
Date Posted January 04, 2013
Recall Number Z-0640-2013
Product Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N 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/BottleLot Number: C0099091A P0099091A C0100101 H P0100101 H C0103042C P0103042C
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood, Massachusetts 02062-4637
For Additional Information Contact Mark Smith
781-269-3158
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).
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 1130
Distribution Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
 
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