TEM Systems Inc recalls ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation pr…

Recall date

September 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0302-2017

FDA classification

Class II

Brand / firm

TEM Systems Inc

Sold / distributed

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.

Why it was recalled

Customers complained of low/empty reagent vials.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.