Haemonetics TEG Hemostasis System Level II Control — Class II medical device recall Z-1130-2015
Terminated recall by Haemonetics Corporation, reported 2015-02-25. Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the m
| Recall number | Z-1130-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haemonetics Corporation, Braintree, MA, United States |
| Recall initiated | 2015-01-26 |
| Classified | 2015-02-19 |
| Reported by FDA | 2015-02-25 |
| Terminated | 2015-06-05 |
| Countries outside the US | CA, CZ, DK, GB, SE |
| Quantity | 4,143 kits |
| Lot numbers | 9200HMO, 9217HMO, 9226HMO, 9232HMO, 9276HMO, 9285HMO, 9292 |
| Model numbers | 8002 |
| Expiration dates | 2017-01 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1130-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.