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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00658-1
Product Name/Description	Phenocell B 0.8% and 3% and Abtectcell III 0.8%RhD. An in vitro diagnostic medical device (IVD) Phenocell B 0.8% Item Number: 26530201 Lot Number: 2653164 Cell Number: Cell #6 Phenocell B 3% Item Number: 16640201 Lot Number: 1664164 Cell Number: Cell #6 Abtectcell III 0.8% RhD Negative Screening Cells Item Number: 22230201 Lot Number: 2223123 Cell Number: Cell #1 Expiry Date: 12/06/2017 ARTG Number: 223867
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	5/06/2017
Responsible Entity	Seqirus Pty Ltd
Reason/Issue	Seqirus has identified that Donor #4138503 was listed as D - (Negative) on the Antigen Composition Sheet(s) provided with the affected products. Subsequent testing of this Donor has indicated weak D reactivity. Donor #4138503 may be agglutinated by some examples of anti D and the weak D antigen expression of this donor is only detectable by some test methods. This donor has been identified as a possible weak D variant.
Recall Action	Recall for Product Correction
Recall Action Instructions	Seqirus has provided users with an interim workaround in the Customer Letter. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	03 9389 2000 - Seqirus