Known Identifiers & Locations
FEI Numbers
3005261996
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0030-2012 |
Minutex D-Dimer ; Trinity Biotech plc,
Bray,
Co. Wicklow,
Ireland.
Tel: (353) 1 276 9800,
Fax: (353) 1 276 9888,
Web: www.trinitybiotech.com
Minutex D-Dimer is a latex agglutination test for semiquantitative determination of fibrin D-Dimer.
Reason: There is a performance issue with Minutex D-Dimer Kit which may cause false negative results for patient samples containing levels of greater than 250ng/mL D-Dimer.
|
2011-06-13 |
Terminated
|
View Details
|
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