# FDA recall Z-2486-2019

> **Instrumentation Laboratory Co.** · Class II · device recall initiated 2019-07-23.

## Product

ROTEM ex-tem  Canada Part No:  503-05-CA

## Reason for recall

Prolonged clotting times

## Distribution

States:  IL  WI  MI    Canada, Spain, Portugal, Poland, Italy, Israel, Switzerland, Denmark, Kazakhstan, United Kingdom, Germany, Netherlands, Belgium, France, Jordan, India, Hong Kong, Austria, Czechia, Australia, Sri Lanka, Argentina, Vietnam, Singapore, Japan, South Korea, Cyprus, Ireland, Hungary, Sweden, Serbia.

## Key facts

- **Recall number:** Z-2486-2019
- **Recalling firm:** Instrumentation Laboratory Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-23
- **Report date:** 2019-09-18
- **Termination date:** 2020-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bedford, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2486-2019

## Citation

> AI Analytics. FDA recall Z-2486-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2486-2019. Source: US FDA. Licensed CC0.

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