Recall Z1006-2010 ยท NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Roche Molecular Systems, Inc.
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
| Date | Mar 5, 2010 (initiated Mar 12, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 9624 kits |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033612 | FACTOR II (PROTHROMBIN) G20210A KIT Roche Diagnostics Corp., Dec 18, 2003 |