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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00825-1
Product Name/Description HemoCue Hb 201 Microcuvettes (an in vitro diagnostic medical device (IVD))

Lot Numbers: 12086555, 1208660, 1209669, 1209674, 1210688, 1211697, 1301708, 1301717, 1322723, 1303734

ARTG Number: 137082
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 8/08/2013
Responsible Entity HemoCue Australia Pty Ltd
Reason/Issue Hemocue has become aware of a production related problem that affects some single pack pouches of certain lots of HemoCue Hb 201 microcuvettes, where the foil within the pouch has been damaged. If a single pack pouch is damaged, the microcuvettes can be exposed to moisture the cuvettes will not fill properly and no measurement will be given.
Recall Action Recall for Product Correction
Recall Action Instructions HemoCue is asking users to discard any affected microcuvettes as per the Instructions for Use. Replacement of affected units can be arranged by consulting HemoCue.
Contact Information 1800 623 910 - HemoCue Australia