Recall Z-2486-2019
Instrumentation Laboratory Co. · initiated July 23, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ROTEM ex-tem Canada Part No: 503-05-CA
Codes / lots: Lot # : 42255801 (Canada)
Reason for recall
Prolonged clotting times
FDA-determined cause: Nonconforming Material/Component
Action taken
-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. -Return the completed and signed form confirming lot destruction and quantities to: FAX No. 781-861-4207 or Email: ra-usa@ilww.com For Technical Questions: Call ROTEM PBM Technical Support Center at 1-800-678-0710, Option # 4 For Replacement Lot: Call IL Customer Service Center at 1-800-955-9525, Option # 0
Details
- Recall number
- Z-2486-2019
- Initiated
- July 23, 2019
- Terminated
- April 27, 2020
- Product code
- JPA – System, Multipurpose For In Vitro Coagulation Studies
- 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, Sweden, Serbia.
- Recalling firm
- Instrumentation Laboratory Co., Bedford, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2485-2019 Class II | ROTEM ex-tem; US Part No: 503-05-USProlonged clotting times | 07/23/2019Terminated |
| Z-2487-2019 Class II | ROTEM ex-tem Rest of the world part No: 503-05 (ROW)Prolonged clotting times | 07/23/2019Terminated |