Class 2 Device Recall Dimension LIP Flex Reagent Cartridge

• Date Initiated by Firm: March 10, 2010
• Date Posted: December 10, 2010
• Recall Status: Terminated on August 04, 2011
• Recall Number: Z-0588-2011
• Recall Event ID: 55571
• 510(K)Number: K952816
• Product Classification: Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
• Product: Dimension LIP Flex Reagent Cartridge, Catalog# DF55A
• Code Information: Lot Number: DE0320, FC0306, GB0342, EA0334, FB0278, DA0293, GB0286, FA0355, EA0362, EB0362.
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 500 GBC Drive, Mailstop 514; PO BOX 6101; Newark DE 19714-6101
• For Additional Information Contact: Siemens Technical Solutions Center; 800-441-9250
• Manufacturer Reason for Recall: Open Well instability: After calibration, QC shifts high (out of range) after the Flex Well is hydrated. Shifts of up to 20% have been observed in both QC and patient samplesas soon as two hours post hydration.
• FDA Determined Cause: Other
• Action: Recalling firm issued "Urgent Field Safety Notice", dated March 2010, informing users of the problem and to transition to the revised Lipasae method.
• Quantity in Commerce: 21171
• Distribution: Nationwide Distribution throughout the US.
• 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 = CHI and Original Applicant = DUPONT MEDICAL PRODUCTS