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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00593-1
Product Name/Description IH-1000. An in vitro diagnostic medical device (IVD)

All software versions are affected
Product reference: 001000
ARTG Number: 184446
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 13/06/2013
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue In some specific conditions, inconsistent grading between the results in the well/card and the results returned by the IH-1000 may be observed. In these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images.
Therefore this issue might lead to a wrong result released to the host if the 3 following conditions are met:
1 A result is returned as negative while the reaction is positive, Double Population, or requires a human interpretation and,
2. This negative result is consistent with the global interpretation of the test and,
3. The system is configured without the second reading function activated for all tests results.
Recall Action Recall for Product Correction
Recall Action Instructions Bio-Rad are providing work around instructions as an interim measure. A software update will be implemented to permanently correct the issue.
Contact Information 1800 224 354 - Bio-Rad Product Specialist