FDA Device recall Z-1130-2015
Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002
- FDA Device
- Class II
- terminated
- Published 2015-02-25
On 2015-02-25 the FDA classified a Class II recall of Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002 by Haemonetics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1130-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-26 |
| Published | 2015-02-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Haemonetics |
| Distribution | n/a |
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.
Identifiers
| code_info | Lot numbers: HMO 9200 HMO 9217 HMO 9226 HMO 9232 HMO 9276 HMO 9285 HMO 9292 Exp. Date 1/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1130-2015%22
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