Instrumentation Laboratory Co.: Medical Device Recall in 2019 - (Recall #: Z-2486-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 23, 2019

Date Posted: September 18, 2019

Recall Number: Z-2486-2019

Event ID: 83523

Reason for Recall:

Prolonged clotting times

Status: Terminated

Product Quantity: 44 kits

Code Information:

Lot # : 42255801 (Canada)

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated