Siemens Healthcare Diagnostics recalls two batches of Thrombin Reagent Kits that may produce unexpectedly long Thrombin Time results, potentially exceeding normal limits. Affected kits have specific lot numbers and were distributed globally.
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).
Siemens Healthcare Diagnostics is recalling two specific batches of Thrombin Reagent Kits that can produce unusually long Thrombin Time results for normal samples. This could lead to test results exceeding the acceptable range, which might affect medical diagnoses.
The recalled Thrombin Reagent Kits may produce test results that are significantly longer than expected for normal samples. This could cause false indications of blood clotting issues, potentially leading to incorrect medical decisions.
Healthcare professionals using these kits for blood tests may be affected. The risk is low as the issue only impacts test results, not patient safety directly.
Check for lot numbers 46751 (UDI: 008427680131024675120180908) or 47184 (UDI: 008427680131024718420190221) on the kit packaging. These kits were distributed globally between 2016 and 2019.
Look for lot numbers 46751 or 47184 on the kit packaging to confirm if it is affected.
The recalled kits may produce unexpectedly long Thrombin Time results for normal samples, which could lead to incorrect medical interpretations.
Check the lot number on the kit packaging. Affected kits have lot numbers 46751 (UDI: 008427680131024675120180908) or 47184 (UDI: 008427680131024718420190221).
The recall does not require immediate action. Check the lot number and contact Siemens Healthcare Diagnostics if you need further assistance.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0827-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0827-2018 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
