Reported Mar 7, 2018 · Terminated
BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number…
Siemens Healthcare Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | BC Thrombin Reagent Kit Lot Number 46751 |
| 2 | UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184 |
| 3 | UDI -008427680131024718420190221 |
| 4 | BC Thrombin Reagent |
| 5 | Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated human plasma. |
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 Lot 46751: 3673 kits BC Thrombin Reagent Kit 2 Lot 47184: 3958 kits Total kits Distributed to Customers Domestic and Foreign: BC Thrombin Reagent Kit 3 Lot 46751: 3549 kits BC Thrombin Reagent Kit 4 Lot 47184: 2580 kits Product Code/ 5 Lot# Date Manufactured Date Expired 46751 2016-11-01 2018-09-08 47184 2017-03-20 2019-02-21 - Amount recalled
- 7631 units
Where it was sold
- Nationwide
Why it was recalled
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) results for expected normal samples, and may recover above the upper limit of normal (< 21 sec.) as stated within the IFU (Instruction For Use).
This product could cause temporary or reversible health problems — stop using it.
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