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.
This recall has been terminated (originally issued February 19, 2015).
- Company
- Haemonetics Corporation
- Recall Initiated
- January 26, 2015
- Posted
- February 19, 2015
- Terminated
- June 5, 2015
- Recall Number
- Z-1130-2015
- Quantity
- 4,143 kits
- Firm Location
- Braintree, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.
Lot / Code Info
Lot numbers: HMO 9200 HMO 9217 HMO 9226 HMO 9232 HMO 9276 HMO 9285 HMO 9292 Exp. Date 1/2017
Root Cause
Process control
Action Taken
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 product is needed. If any affected product has been forwarded to other locations, customers are to inform them of the recall. Please call the Technical Support team at 1-800-438-2834, with questions about this action.