Device product
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.
Z-0302-2017
Product summary
- Firm
- TEM Systems Inc
- Event
- Event 75265
- Status
- Terminated
- Classification
- Class II
- Quantity
- 637 boxes x 10 vials
- Official record key
device-enforcement:Z-0302-2017
Official wording
Reason: Customers complained of low/empty reagent 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.
Derived failure modes
-
Unknown
Customers complained of low/empty reagent vials.