ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnos
FDA device recall Z-0637-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Microgenics Corporation
- Reason for recall
- Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges.
- Action taken
- On 12/14/2011, ThermoFisher Scientific issued letters via express mail to all its direct consignees, informing them of the affected products and providing instructions on the recall.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JJY
- Quantity affected
- 25,113 Kits
- Distribution
- Nationwide and Worldwide, including Germany, France, Italy and Spain.
- Date initiated
- 2011-12-14
- Date posted
- 2012-01-11
- Date terminated
- 2012-10-26
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOIMMUNE XL CARDIAC MARKER CONTROL (K061196) | Microgenics Corp. | 2006-05-30 |