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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00099-1
Product Name/Description D-10 Rack Loader. An in vitro diagnostic medical device (IVD).

Catalogue Number: 220-0600

ARTG Number: 212703
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 3/02/2016
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue There is a potential for a sample and result to be mismatched when running in the D-10 Rack Loader configuration. This means that a patient result may be assigned to an incorrect sample ID. While only two instances have been reported, Bio-Rad wants users to be aware of the possibility.
Recall Action Recall for Product Correction
Recall Action Instructions Bio-Rad is investigating the reported issue and preparing a permanent solution. In the interim, users are advised to not skip positions within the rack. While reviewing results, check the Daily Summary for the following:
A. Confirm that the number of results equals the total number of samples run.
B. Confirm that injection numbers (I#) within an individual rack (R#) are consecutive.
C. Confirm that any sample that was assigned an auto-generated Sample ID is actually missing a barcode label on the sample tube.

Bio-Rad Laboratories will release a follow-up communication providing a permanent solution upon completion of a thorough investigation.
Contact Information 1800 224 354 - Bio-Rad Laboratories