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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-01195-1
Product Name/Description IH-1000 (immuno-haematology instrument). An in vitro diagnostic medical device (IVD)

Catalogue Number: 001000V

Affected Version - All Software

ARTG number: 184446
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 10/11/2014
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue Further to a customer complaint, Bio-Rad have confirmed that in the specific conditions detailed below, the IH-1000 software may lose the link sample/”test in progress”. This loss might lead to a mismatch between the test result and the patient sample.

This issue is linked to the sample management when using the “emergency* button” and might occur ONLY in the following conditions:
- A Not Urgent rack (green label) is inserted with more than one sample AND;
- ALL the samples on this rack are manually selected as “Emergency” by clicking on the “Emergency* button”;
Then once the first emergency sample is processed, the instrument ejects the rack before all processing is completed.
- If a rack is then reloaded with new samples in the exact same positions and reinserted in the same slot, the link sample/”test in progress” is lost.
Recall Action Recall for Product Correction
Recall Action Instructions This issue will be permanently corrected in the next IH-1000 software version. This version will be released by the end of Q1 2015.

In the meantime, customers should immediately discontinue using the “emergency button” and should process all emergency samples exclusively on the urgent rack.
This action has been closed-out on 21/03/2018.
Contact Information 1800 224 354 - Bio-Rad Laboratories Technical Support