Recall Z-1130-2015 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Haemonetics Corporation
Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.
| Date | Feb 19, 2015 (initiated Jan 26, 2015) |
| Status | Terminated |
| Reason | Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter. |
| Root cause | Process control |
| Action | Haemonetics issued on 1/26/15, an Urgent Medical Device Recall to consignees The letter identified the affected product, the reason for the recall, as well as the risk to health. It instructs consignees to inspect their stock and determine if they have any of the affected lots. Customers are to immediately discontinue use and discard as instructed any affected product. The attached customer acknowledgment form should be completed and returned whether or not customers have any affected product. Customers are to contact their local service representative at 1-800-537-2802 if replacement pro |
| Quantity | 4,143 kits |
| Distribution | Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002177 | THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES Haemoscope Corp., Sep 14, 2000 |