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.
Reported: February 25, 2015 Initiated: January 26, 2015 #Z-1130-2015
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.
Details
- Recalling Firm
- Haemonetics Corporation
- Units Affected
- 4,143 kits
- Distribution
- Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.
- Location
- Braintree, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Haemonetics Corporation. Units affected: 4,143 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 25, 2015. Severity: Moderate. Recall number: Z-1130-2015.
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