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U.S. Department of Health and Human Services

Class 2 Device Recall FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument

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 Class 2 Device Recall FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrumentsee related information
Date Initiated by FirmMarch 12, 2009
Date PostedMarch 05, 2010
Recall Status1 Terminated 3 on June 09, 2010
Recall NumberZ1006-2010
Recall Event ID 53708
510(K)NumberK033612 
Product Classification Test, factor ii g202 10a mutations, genomic dna pcr - Product Code NPR
ProductFACTOR 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
Code Information All lots between 12/18/03 and 4/16/09.
Recalling Firm/
Manufacturer		 Roche Molecular Systems, Inc.
1080 Us Highway 202 S
Somerville NJ 08876-3733
For Additional Information ContactVincent C. Stagnitto
908-253-7569
Manufacturer 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.
FDA Determined
Cause 2		Labeling design
ActionProduct 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 Commerce9624 kits
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NPR
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