Z-1653-2011

Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN The Factor V Leiden Kit...

Name: Z-1653-2011 Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN The Factor V Leiden Kit...
Creator: Roche Diagnostics Operations, Inc.
Published: 2010-10-26
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2010-10-26 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN The Factor V Leiden Kit allows the detection and genotyping of a single... on 2010-10-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1653-2011
Status: Terminated
Initiated: 2010-10-26
Posted: 2011-03-14
Terminated: 2011-08-30
Recalling firm: Roche Diagnostics GmbH
Product: Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN The Factor V Leiden Kit allows the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation, 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 V DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection of genotyping of the amplified Factor V DNA. The Factor V Leiden test is an in vitro diagnostic test for the detection and genotyping of the Factor V Leiden mutation as an aid to diagnosis 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.
Product code: NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
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.
Root cause tag: software
FDA root 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.
Product codes and lots: n/a

Product code NPQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)