FDAClass IIJuly 31, 2013

TEG 5000 Thromboelastograph Coagulation Analyzer recall

TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies

Why was TEG 5000 Thromboelastograph Coagulation Analyzer recalled?

Research Use Only (RUO) parameters were included in TEG 5000 User Manual.

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?

Per recall strategy.

Product
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Recalling firm
Haemonetics Corporation
Quantity
1590 devices
Distribution
US Nationwide
Recall date
July 31, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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