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.
FDA Recall Z-1652-2011 · Posted 2011-03-14
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Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeNPR
Date Initiated2010-10-26
Date Terminated2011-08-30
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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