Z-0302-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 2, 2016
- Initiation Date
- September 13, 2016
- Termination Date
- December 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 637 boxes x 10 vials
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.
Reason for Recall
Customers complained of low/empty reagent vials.
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.
Code Information
Lot No. 21929007