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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00829-1
Product Name/Description Phenocell C 0.8% and Phenocell C 3%. An in vitro diagnostic medical device (IVD)

Phenocell C 0.8%
Lot number: 9653 054

Phenocell C 3%
Lot number: 8664 054
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 5/08/2013
Responsible Entity bioCSL Pty Ltd
Reason/Issue bioCSL carried out confirmatory testing on all products potentially supplied with incorrect phenotype information ie, donor 1 was Lu-a positive whereas the Antigen Composition sheet stated donor 1 as Lu-a negative. In addition to confirming the Lu-a inconsistency, testing identified that the donor was Co(b) positive whereas the Antigen Composition Sheet indicated donor as Co(b) negative.
Recall Action Recall for Product Correction
Recall Action Instructions bioCSL is providing end users with an updated Antigen Composition Sheets for affected kits. The updated information is also provided online at
Contact Information 03 9389 1000 - bioCSL Immuno Haematology