| ||Class 3 Recall|
Siemens ChekStix Combo Pak
||January 04, 2013
||Siemens Chek-Stix Combo Pak
Catalog Number: 1364
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
||Carton/Bottle Lot Number:
|Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood, Massachusetts 02062-4637
|For Additional Information Contact
|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).
||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
||Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,