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Test Thrombin Reagent
Siemens Healthcare Diagnostics Products GmbH · Model 10873894 · UDI-DI 00630414639635
1
510(k) clearances
15
Adverse events
4
Recalls
7
Facilities
Description
Determination of thrombin time in human plasma
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-10-17 | Siemens Healthcare Diagnostics | The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged Thrombin Time (TT |
| 2004-08-20 | bioMerieux | Complaints were received from the field regarding prolonged clot times, high control values and erratic results. |
| 2004-08-20 | bioMerieux | Complaints were received from the field regarding prolonged clot times, high control values and erratic results. |
| 2004-07-21 | Dade Behring , Inc. | The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin |
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