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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00321-1
Product Name/Description DiaClon ABO/D+ Reverse Grouping for Patients. An in vitro diagnostic medical device (IVD).

Catalogue Number: 001267

Displayed Lot Number: 50093 87 17

SAP Lot Number: 2201808717

Expiry Date: 31/01/2019

ARTG Number: 212527
(Bio-Rad Laboratories Pty Ltd - Multiple blood grouping and typing IVDs)
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 24/04/2018
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue Bio-Rad have been made aware that a limited amount of ID-Cards DiaClon ABO/D + Reverse Grouping for Patients, lot 50093 87 17, were packed in boxes stating a storage temperature range of 2-8°C on the outer carton instead of 18-25°C for this product.
The product label shows the correct storage conditions for this product. This issue has no impact on product used prior to May 1 2018.
Recall Action Product Defect Correction
Recall Action Instructions Bio-Rad is advising users to inspect their inventory to confirm that the affected lot has been stored between 18-25°C and not 2-8°C. If for any reason the product is stored at 2-8°C, please discard product after 1st May 2018.

This action has been closed out on the 15/11/2018.
Contact Information 1800 224 354 - Bio-Rad Laboratories