Print version of this report
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