Haemonetics TEG Hemostasis System Level II Control recall
Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph…
Why was Haemonetics TEG Hemostasis System Level II Control recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers: HMO 9200 HMO 9217 HMO 9226 HMO 9232 HMO 9276 HMO 9285 HMO 9292 Exp. Date 1/2017
- Product
- Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph…
- Recalling firm
- Haemonetics Corporation
- Quantity
- 4,143 kits
- Distribution
- Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.
- Recall date
- February 25, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)