Recall Z-1130-2015— Haemonetics Corporation
Class II · Terminated
Class II FDA medical device recall by Haemonetics Corporation, initiated 2015-01-26, terminated 2015-06-05. It names one FDA 510(k) clearance: K002177. 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.. 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..
- Recalling firm
- Haemonetics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-26
- Terminated
- 2015-06-05
- Firm location
- Braintree, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.