TEM Systems Inc: Medical Device Recall in 2016 - (Recall #: Z-0302-2017)

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:

ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.

Product Classification:

Class II

Date Initiated: September 13, 2016

Date Posted: November 2, 2016

Recall Number: Z-0302-2017

Event ID: 75265

Reason for Recall:

Customers complained of low/empty reagent vials.

Status: Terminated

Product Quantity: 637 boxes x 10 vials

Code Information:

Lot No. 21929007

Distribution Pattern:

Nationwide Distribution -- AR, CA, DC, GA, HI, ID, IL, IN, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated