Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00804-1
Product Name/Description chromID S.aureus agar (SAID/MRSA). An in vitro diagnostic medical device (IVD)

chromID S.aureus agar (SAID)
Lot Numbers: 1004119200, 1004044190, 1004085400

chromID MRSA agar / chromID S. aureus agar (MRSA/SAID)
Lot Numbers: 1004158090, 1004091980, 1004113000, 1004141170

ARTG Number: 182081

An in vitro diagnostic medical device (IVD)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 26/08/2015
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue During an internal investigation, bioMérieux observed an anomaly on nine (9) lots of chromID S. aureus manufactured with the same semi-finished lot.

This anomaly is causing a delayed colouration of the colonies which appear white/light green instead of green resulting in a potential false negative result.

Biochemical and/or immunological tests must be performed to identify colonies other than green ones (white, pink or mauve): therefore, the risk of delivering a false negative result is mitigated if the instructions for use have been followed.
Recall Action Recall for Product Correction
Recall Action Instructions Biomerieux is advising users to discontinue use and discard any remaining inventory of the affected product.
Biomerieux advises that users should discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 18/08/2016.
Contact Information 1800 333 421 - bioMerieux Technical Assistance Department