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Recall Observatory FDA recall evidence

Device 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.

Z-1130-2015

January 26, 2015

Class II

Product summary

Firm
Haemonetics Corporation
Event
Event 70352
Status
Terminated
Classification
Class II
Quantity
4,143 kits
Official record key
device-enforcement:Z-1130-2015

Official wording

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.

Code information: Lot numbers: HMO 9200 HMO 9217 HMO 9226 HMO 9232 HMO 9276 HMO 9285 HMO 9292 Exp. Date 1/2017

Distribution pattern: Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.