TEM Systems Inc: Medical Device Recall in 2016 - (Recall #: Z-1090-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.

Product Classification:

Class II

Date Initiated: February 18, 2016

Date Posted: March 16, 2016

Recall Number: Z-1090-2016

Event ID: 73357

Reason for Recall:

Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 2016.

Status: Terminated

Product Quantity: 476 boxes x 5 vials

Code Information:

Lot 41925401

Distribution Pattern:

Distributed in the states of AZ, AR, CA, FL, GA, HI, ID, IL, IN, LA, MD, MA, MN, MO, NE, NJ, NM, NY, PA, OH, SC, SD, TN, TX, UT, WA, WV and the country of Germany.

Voluntary or Mandated:

Voluntary: Firm initiated