Class 2 Device Recall Factor II (prothrombin) G20210A kit

• Date Initiated by Firm: October 26, 2010
• Date Posted: March 14, 2011
• Recall Status: Terminated on August 30, 2011
• Recall Number: Z-1652-2011
• Recall Event ID: 57534
• 510(K)Number: K033612
• Product Classification: Test, factor ii g20210a mutations, genomic dna per - Product Code NPR
• Product: Factor II (prothrombin) G20210A kit, catalog number 03610195001, Roche Diagnostics, Indianapolis, IN ; ; The Factor II (prothrombin) G20210A kit allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human factor II gene, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler 2.0 instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor II DNA recovered from clinical samples snd fluorigenic target-specific hybridization for the detection and genotyping of the amplified Factor II DNA. The Factor II (prothrombin) G20210A test is an in vitro diagnostic test for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation as an aide to dignosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler 2.0 instrument using the LightCycler Software 4.05 or 4.1.
• Code Information: n/a
• Recalling Firm/ Manufacturer: Roche Diagnostics Operations, Inc.; 9115 Hague Road; Indianapolis IN 46256-1025
• For Additional Information Contact: 317-576-2000 Ext. 249
• Manufacturer Reason for Recall: If the bar code is printed from the Batch Results Screen, a wrong batch ID may be printed, while the correct batch ID is still assigned to the batch in the data repository of the MPLC 2.0 software. This may result in sample mis identification. If printed from the ordering screens, the bar code is printed with the correct batch ID.
• FDA Determined Cause: Software design
• Action: The firm, Roche, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 04, 2010 to its customers. The letter described the product, problem and action to be taken. The customers were instructed to print batch ID barcode labels from the ordering or stage set up screens only; print Cooling Block barcode labels from the Post Elution Edit screen only; complete and return the attached UMDC Faxback Form for MagNA Pure LC 2.0 Instrument [UMDC 10-228] via fax to 1-877-551-7152 and file this correction notice for future reference. The firm plans to issue a software update in first quarter 2011. If you have questions about the information contained in this UMDC, for Clinical customers, please contact Roche Molecular Diagnostics Technical Service at 1-800-526-1247; for Research customers, please contact Roche Applied Sciences Technical Service at 1-800-262-4911.
• Distribution: Worldwide distribution: AL, AZ, CA, CO, DC, FL, GA, HI, IL, KY, LA, MA, MD, ME, MN, MO, MT, NC, ND NE, NH, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, VT, WI and Puerto Rico; and country of Europe.
• 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 = NPR and Original Applicant = ROCHE DIAGNOSTICS CORP.