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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00954-1
Product Name/Description	Cobas b 101 HbA1c Test (used to test for diabetes) Material Number: 06378676190 Lot Number : All lots (303022-01, 304021-01, 304022-01, 304023-01, 304024-01, 304025-01, 305021-01, 306022-01, 306023-01 & 307021-01) within shelf life are affected System affected: Cobas b 101 An in vitro diagnostic medical device (IVD)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	11/09/2013
Responsible Entity	Roche Diagnostics Australia Pty Limited
Reason/Issue	Detailed investigations have confirmed a deviation in the HbA1c result in the range of -10% to up to -30% from the target value with an error rate of up to 40%.
Recall Action	Recall
Recall Action Instructions	Roche is requesting their customers to discard any affected HbA1c. Destroyed product will be replaced with new stock once it is available.
Contact Information	1800 645 619 - Roche National Support Centre