Class 3 Device Recall Siemens ChekStix Combo Pak

• Date Initiated by Firm: November 21, 2012
• Date Posted: January 04, 2013
• Recall Status: Terminated on November 06, 2014
• Recall Number: Z-0639-2013
• Recall Event ID: 63809
• 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 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 25C (77F).
• FDA Determined Cause: 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 25C (77F). You can use the reconstituted positive control solution for up to eight hours if the solution is held at 25C (77F) or lower. If the operating temperature is greater than 25C and lower than 30C (77F and 86F), 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 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