FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 001 Cont. 1 FIIG20210A MD Mix,
FDA device recall Z1006-2010 · posted 2010-03-05 · Terminated
Recall details
- Recalling firm
- Roche Molecular Systems, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- NPR
- Quantity affected
- 9624 kits
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-03-12
- Date posted
- 2010-03-05
- Date terminated
- 2010-06-09
- Location
- Somerville, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FACTOR II (PROTHROMBIN) G20210A KIT (K033612) | Roche Diagnostics Corp. | 2003-12-18 |