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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00913-1
Product Name/Description BacT/ALERT PF Plus Culture Bottle. An in vitro diagnostic medical device (IVD)

Catalogue Number: 410853

Lot Number: 1033298

Expiration Date: 16 October 2013
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 30/08/2013
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue BacT/ALERT PF PLUS Culture Bottle, lot 1033298, yielded reflectance results above the stability specification at the 9-month time frame. Bottles that have reflectance results near or greater than the initial value threshold specification when first loaded on the instrument could have an increased probability of false positive results.
Recall Action Recall
Recall Action Instructions Bio Merieux is requesting their customers to discontinue use of the affected batch remaining in stock. Bottles that are already inoculated or incubating should be allowed to complete their testing/incubation. All bottles flagged positive by the instrument should continue to be treated as stated in the instructions for use.
Contact Information 1800 333 421 - bioMerieux Technical Department