Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08
FDA device recall Z-2566-2011 · posted 2011-06-14 · Terminated
Recall details
- Recalling firm
- Roche Molecular Systems, Inc.
- Reason for recall
- Roche Molecular Systems has decided to discontinue marketing the Factor II (Prothrombin) G20210A Kit and the Factor V Leiden Kit for use with the Light Cycler 2.0 Instrument in the US Market
- Action taken
- Roche sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 31, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The customer was instructed to discontinue use of the affected product by August 31, 2011. Complete the attached faxback form ( 4293-00-0311 ) and fax it to 1-888-345-5359. For questions or technical support, please contact Roche Molecular at 1-800-526-1247,
- Root cause
- Other
- Status
- Terminated
- Product code
- NPQ
- Quantity affected
- 17,026 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-03-31
- Date posted
- 2011-06-14
- Date terminated
- 2012-08-13
- Location
- Somerville, NJ
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