Class II — Siemens Healthcare Diagnostics
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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). |
| 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. |
| Quantity | 7631 units |
| Distribution | Worldwide distribution. US nationwide, Austria, Belgium, Bosnia-Herzegovina, Croatia, Finland, France (incl. Guadeloupe, Martinique, Reunion, French Guinea overseas departments), Germany, Greece, Hungary, Italy, Kazakhstan, Macedonia, Latvia, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey, Argentina, Brazil, El Salvador, Mexico, Peru, … |
| Initiated | 2017-10-17 |
| Classified | 2018-03-01 |
| Terminated | 2019-11-04 |
| Recall number | Z-0827-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics (Z-0827-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79053/
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