Haemonetics Corporation: Medical Device Recall in 2015 - (Recall #: Z-1130-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 26, 2015

Date Posted: February 25, 2015

Recall Number: Z-1130-2015

Event ID: 70352

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.

Status: Terminated

Product Quantity: 4,143 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated