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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00456-1
Product Name/Description IH-1000 Immunohaemotology Analyser. An in vitro Diagnostic Medical Device (IVD)

Product REF: 001000
All software versions

ARTG number: 184446
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 16/05/2013
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue An error relative to the liquid reagents management (test cells or anti-serum vials) might occur if the following conditions are present:
1. IH-1000 is in status “ready to start” and:
2. The user requests the unloading of a reagent rack while the system is creating the internal batch (the time slot during which the error could occur is about 2 seconds);
3. Another is loaded immediately afterwards in the same position.

If all three conditions are present, the IH-1000 may not use the full set of liquid reagents required to perform the tests of the ongoing batch.Due to a software failure, the system may only use the vial placed in the first position of the re-loaded rack for all the tests of the ongoing batch
Recall Action Recall for Product Correction
Recall Action Instructions Bio-Rad is providing end users with work around instructions to mitigate the risk of incorrect results. A permanent correction will be made in the next software update.
Contact Information 1800 224 354 - Bio-Rad Laboratories