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TGA Action ID	RC-2026-RN-00640-1
Type of Product	Medical Device
Product Name/Description	D-100 Hemoglobin A1c Analytical Calibrator/Cartridge Pack. An in vitro diagnostic medical device (IVD). Catalogue Number: 290-1004 Affected Lots: 64714383, 64714384, 64714387, 64715656, 64723045, 64723047, 64725076, 64725077, 64725079, 64725084, 64725085, 64741569, 64741570, 64741572, 64741573, 64750745 Expiry Dates: 31 August 2027, 30 September 2027, 29 February 2028
ARTG Number	175078
Action Type	Product Alert
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Bio-Rad has identified two (2) problems affecting D-100 Hemoglobin A1c Analytical Calibrator/Cartridge Packs: 1. Peak separation degradation may be observed between 4000-7000 injections, characterised by the merging of P3 and A0 peaks, which may trigger flags and may not follow acceptance criteria as defined in the Guidelines for the Interpretation of Result in the D-100 HbA1c Instructions for Use. 2. Low-pressure error - upon insertion of a new cartridge, the system may detect low-pressure during calibration. The system will generate a low pressure error (error code 133207 – “The pressure is too low when running gradients”) and calibration cannot complete. To date, no adverse events have been reported due to these problems.
Instructions for Customers/Users	- Bio-Rad is requesting that customers affected by this Product Alert to follow the instructions outlined in the Customer Letter for continued use of the product. - If additional support is required, please contact Bio-Rad Technical Support to report the problem. Bio-Rad is actively investigating these problems to determine root cause and identify appropriate solutions. Additional updates and recommendations will be provided when available.
Action Commencement Date	31/08/2026
Responsible Entity	Bio-Rad Laboratories Pty Ltd
Contact Information	(02) 9914 2800 - Bio-Rad