Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0827-2018 — 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 t

U.S. FDA — Device Enforcement · United States · 2017-10-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0827-2018
Date of alert: 2017-10-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Healthcare Diagnostics
Product category: device
Product type: Devices

Reported risk: 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).

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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