| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00305-1 |
| Product Name/Description |
Panocell-20 and Capture-R Ready-ID. An in vitro diagnostic medical device (IVD).
Panocell-20
Item Number: 5020
Lot Number: 52872
Cell Number: Cell #11
Expiry: 3 March 2017
Capture-R Ready-ID
Item Number: 66214
Lot Number: ID324
Cell Number: Cell #4
Expiry: 2 May 2017
ARTG Number: 245555
ARTG Number: 245555 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
3/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Immucor has identified issues with Panocell-20 and Capture-R Ready-ID.
For Panocell-20, Donor E1011 was listed as V+ (positive) on the Master List supplied with this product. The donor has subsequently been tested as V - (negative). Since donor E1011 is V–, Cell number 11 will be nonreactive with specimens that may contain anti-V. V (RH10) is a low prevalence antigen in the RH system.
For Capture-R Ready-ID, Donor D1741 was listed as V+ (positive) on the Master List supplied with this product. DNA Testing of this donor has confirmed the donor as V - (negative). Since donor D1741 is V–, Cell number 4 will be non-reactive with specimens that may contain anti-V. V (RH10) is a low prevalence antigen in the RH system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Seqirus is providing revised master lists for the affected products which correctly identify the donors as V- (negative). Seqirus is asking users to evaluate the impact the amended phenotype information may have on results generated with these product lots as per the users' procedures. This action has been closed-out on 05/07/2017. |
| Contact Information |
1800 008 275 - Seqirus Customer Service |