Recall Z-2486-2019 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Instrumentation Laboratory Co.
ROTEM ex-tem Canada Part No: 503-05-CA
| Date | Jul 23, 2019 |
| Status | Terminated |
| Reason | Prolonged clotting times |
| Root cause | Nonconforming Material/Component |
| Action | -Check your inventory for Lot No. 42255901 / 42255801 and destroy all remaining material. - Document the destruction on the Mandatory Tracking Response Record and return the completed and signed form to the fax number or e-mail address listed on the next page. -Contact your local representative for an alternative product lot of ROTEM ex-tem, Part No. 503-05-US / 503-05-CA. -Share this information with your laboratory staff and follow your internal procedures. -Forward this notification to all affected locations within your facility. -Retain a copy of this notification for your records. - |
| Quantity | 44 kits |
| Distribution | States: IL WI MI Canada, Spain, Portugal, Poland, Italy, Israel, Switzerland, Denmark, Kazakhstan, United Kingdom, Germany, Netherlands, Belgium, France, Jordan, India, Hong Kong, Austria, Czechia, Australia, Sri Lanka, Argentina, Vietnam, Singapore, Japan, South Korea, Cyprus, Ireland, Hungary, Sw |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101533 | EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM Tem Innovations GmbH, Aug 10, 2011 |