Z1006-2010

FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 001 Cont. 1...

Name: Z1006-2010 FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 001 Cont. 1...
Creator: Roche Molecular Systems, Inc.
Published: 2009-03-12
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2009-03-12 / Terminated / root cause: labeling and UDI

FDA source

Roche Molecular Systems, Inc. began a recall of FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 001 Cont. 1 FIIG20210A MD Mix, 1 x 78 uL 2. FIIG20210A R mix, 1 x 78... on 2009-03-12. The reason FDA records is "Within the Precautions and Warning Section, Polymorphism heading, of the Product's Package Insert, it stated that mutations at positions 20207, 20209, 20218 and 20221 exist and these mutations are spanned by the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z1006-2010
Status: Terminated
Initiated: 2009-03-12
Posted: 2010-03-05
Terminated: 2010-06-09
Recalling firm: Roche Molecular Systems Inc
Product: FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 001 Cont. 1 FIIG20210A MD Mix, 1 x 78 uL 2. FIIG20210A R mix, 1 x 78 uL 3. FIIG20210A CT, 1 x 50 uL 5, FIIG20210A DIL 1 x 1 mL Manufactured in Germany Distributed by Roche Diagnostics, Indianapolis, IN
Product code: NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Reason for recall: Within the Precautions and Warning Section, Polymorphism heading, of the Product's Package Insert, it stated that mutations at positions 20207, 20209, 20218 and 20221 exist and these mutations are spanned by the mutation probe. These rare mutations will lead to an unknown result after performing genotyping.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Product Advisory Notices were sent via e-mail on 3/12/09 to Roche Local Safety Officers and Roche county General Manager. Local Safety Officers and General Managers were to communicate to the end users with the Important Product Notice. In addition, Reagent Bulletin 09-052, dated 3/27/09, was issued to Roche U.S. Affiliate of U.S. customers.
Quantity in commerce: 9624 kits
Distribution: Nationwide Distribution
Product codes and lots: All lots between 12/18/03 and 4/16/09.

Product code NPR

K033612Class IIFactor II (Prothrombin) G20210a KitRoche Diagnostics Corp. / cleared 2003-12-18

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)