Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00947-1
Product Name/Description Grifols Australia AHG Cards. An in vitro diagnostic medical device (IVD)

Item Codes: 71300048, 71300504 & 71301008

Lot Number: 13059.01

Expiration Date: 10/2014

ARTG Number: 178738
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 13/09/2013
Responsible Entity Grifols Australia Pty Ltd
Reason/Issue Grifols Australia is undertaking a recall due to a potential finding of higher than expected number of cards with wells showing incorrect level of supernatant or cracked gel when they perform the intiial visual check of the cards as stated in the Instructions for Use. The origin of the problem is a production incident in the card sealing process where some cards were incorrectly sealed. This issue will induce supernatant evaporation that finally will lead to incorrect supernatant levels or cracked gel.
Recall Action Recall
Recall Action Instructions End users are requested to quarantine all stock from the affected lot and contact Grifols to arrange for replacement stock. Once replacement stock has been received end users are requested to discard the affected lot in their biological waste.
Contact Information 03 9535 9333 - Grifols Australia