Z-1130-2015Class II

Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological...

Name: Z-1130-2015 Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological...
Creator: Haemonetics Corporation
Published: 2015-01-26
License: https://open.fda.gov/license/

Haemonetics Corporation / initiated 2015-01-26 / Terminated / root cause: manufacturing process

FDA source

Haemonetics Corporation began a recall of Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG)... on 2015-01-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1130-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-26
Posted: 2015-02-19
Terminated: 2015-06-05
Recalling firm: Haemonetics Corporation
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.
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Haemonetics issued on 1/26/15, an Urgent Medical Device Recall to consignees The letter identified the affected product, the reason for the recall, as well as the risk to health. It instructs consignees to inspect their stock and determine if they have any of the affected lots. Customers are to immediately discontinue use and discard as instructed any affected product. The attached customer acknowledgment form should be completed and returned whether or not customers have any affected product. Customers are to contact their local service representative at 1-800-537-2802 if replacement product is needed. If any affected product has been forwarded to other locations, customers are to inform them of the recall. Please call the Technical Support team at 1-800-438-2834, with questions about this action.
Quantity in commerce: 4,143 kits
Distribution: Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.
Product codes and lots: Lot numbers: HMO 9200 HMO 9217 HMO 9226 HMO 9232 HMO 9276 HMO 9285 HMO 9292 Exp. Date 1/2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1130-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1130-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-25	2015-02-19

Product code JPA

K002177Class IIThrombelastograph Coagulation Analyzer Teg-5000 SeriesHaemoscope Corp. / cleared 2000-09-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)