TEM Systems Inc Recall: ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.:
TEM Systems Inc Recall: ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: TEM Systems Inc; Product: ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation proce
| Recalling firm | TEM Systems Inc |
|---|---|
| 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. |
| Reason for recall | Customers complained of low/empty reagent vials. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | 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. |
| Recall initiated | 20160913 |
| Recall number | Z-0302-2017 |
| Category | device |
| State | NC |
| Country | United States |
$29/mo
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