# FDA recall Z-0827-2018

> **Siemens Healthcare Diagnostics** · Class II · device recall initiated 2017-10-17.

## 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.

## 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

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.

## Key facts

- **Recall number:** Z-0827-2018
- **Recalling firm:** Siemens Healthcare Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-17
- **Report date:** 2018-03-07
- **Termination date:** 2019-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0827-2018

## Citation

> AI Analytics. FDA recall Z-0827-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0827-2018. Source: US FDA. Licensed CC0.

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