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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00245-1
Product Name/Description IH-1000 with software version 04.07.02. An in vitro diagnostic medical device (IVD)

Catalogue Number: 001000

ARTG Number: 184446
(Bio-Rad Laboratories - Instrument/analyser IVDs)
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 21/03/2018
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue It has been identified that when a reagent vial with an unreadable barcode is loaded on a reagents rack on IH-1000 (software version 04.07.02) and a test is performed, despite the fact the first reagent is correctly pipetted, the instrument will pipette from the vial with unreadable barcode for all the remaining wells. The system will add serum and continue as normal without alarm.
This error happens following a specific sequence of events:
1. Use IH-1000 in version 04.07.02
2. Load a reagent in a reagent rack
3. The barcode on the reagent vial is not readable
4. Perform a test requiring the reagent with the unreadable barcode
5. Validate the results through IH-Com
Recall Action Product Defect Correction
Recall Action Instructions BioRad is advising customers to restore the previous version of software 04.04.08. Users may contact Bio-Rad Laboratories to arrange for replacement software.
BioRad is advising users to review previous results obtained since the installation of the affected software version. This can be done by checking the lot numbers in the daily journal in IH-Com. If the lot number does not appear do not use the test results and perform the test again.

This action has been closed out on 01/11/2018
Contact Information 1800 224 354 - Customer Service Support