Z-0827-2018Class II

BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot...

Name: Z-0827-2018 BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot...
Creator: Siemens Healthcare Diagnostics
Published: 2017-10-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-10-17 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics began a recall of BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC... on 2017-10-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0827-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-17
Posted: 2018-03-01
Terminated: 2019-11-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: GJA Test, Thrombin Time
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).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 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, Uruguay, Canada, and Australia.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0827-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0827-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code GJA

K970645Class IIBc Thrombin ReagentBehring Diagnostics, Inc. / cleared 1997-05-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)