Home / Recalls / Siemens Healthcare Diagnostics / Z-0827-2018

Z-0827-2018 Class II Terminated

Recalled by Siemens Healthcare Diagnostics — Tarrytown, NY

FDA device recall Z-0827-2018 was initiated by Siemens Healthcare Diagnostics on October 17, 2017 and is designated Class II. 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 expect… The recall status is terminated (terminated November 4, 2019). Affected quantity: 7631 units.

Recall Details

Product Type
Devices
Report Date
March 7, 2018
Initiation Date
October 17, 2017
Termination Date
November 4, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7631 units

Product Description

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 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).

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.

Code Information

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

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FDA data resources