Device product
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.
Z-1130-2015
Product summary
- Event
- Event 70352
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,143 kits
- Official record key
device-enforcement:Z-1130-2015
Official wording
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.
Code information: Lot numbers: HMO 9200 HMO 9217 HMO 9226 HMO 9232 HMO 9276 HMO 9285 HMO 9292 Exp. Date 1/2017
Distribution pattern: Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.
Derived failure modes
-
Unknown
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.