FDA Device recall Z-0827-2018
BC Thrombin Reagent Kit Lot Number 46751
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of BC Thrombin Reagent Kit Lot Number 46751 by Siemens Healthcare Diagnostics, citing 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 (T….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0827-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-17 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated human plasma.
Reason
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).
Identifiers
| code_info | Manufactured: BC Thrombin Reagent Kit Lot 46751: 3673 kits BC Thrombin Reagent Kit Lot 47184: 3958 kits Total kits…Manufactured: BC Thrombin Reagent Kit Lot 46751: 3673 kits BC Thrombin Reagent Kit Lot 47184: 3958 kits Total kits Distributed to Customers Domestic and Foreign: BC Thrombin Reagent Kit Lot 46751: 3549 kits BC Thrombin Reagent Kit Lot 47184: 2580 kits Product Code/ Lot# Date Manufactured Date Expired 46751 2016-11-01 2018-09-08 47184 2017-03-20 2019-02-21 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0827-2018%22
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