Recall Z-1379-2015 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
TEM Systems Inc
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
| Date | Apr 3, 2015 (initiated Oct 23, 2014) |
| Status | Terminated |
| Reason | Some of vials were found to be partially filled. |
| Root cause | Nonconforming Material/Component |
| Action | Tem sent an Dear Customer letter dated October 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You are entitled to return products delivered to you in the event that they are defective or otherwise not in conformity with your order when you received them. If you observe a low level of diluent in a box of Rotrol P lot number 41819801 at your location, please contact us for a free of charge replacement box from a new lot of Rotrol P. You can reach us at: Email: support@roteminc.com Phone: 919-941-7777, Opti |
| Quantity | Total 1574 x 5 vials per box |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |