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Terminated

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.

FDA Recall Z-0827-2018 · Posted None

Recalling FirmSiemens Healthcare Diagnostics
Recall StatusTerminated
Product CodeGJA
Date Initiated2017-10-17
Date Terminated2019-11-04
Product Quantity7631 units

Reason for Recall

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).

Firm Action

Siemens sent an Urgent Field Safety Notice letter dated October 2017 to affected customer. The letter identified the affected product, problem and actions to be taken by the customer. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter and the Urgent Field Corrective Action letter within 30 days. For questions contact your Siemens Customers Care Center or local Siemens technical support representative.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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, Uruguay, Canada, and Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970645BC THROMBIN REAGENTBehring Diagnostics, Inc. · 1997-05-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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