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Manufacturers
Diagnostic Solutions Pty Ltd
Manufacturer Parent Company (2017)
Diploma Plc
Source
DHTGA
11 Events
Recall of OriGen Syringe DMSO (Used for Research Use Only)
Recall of PF4 IgG assay (Thrombophilia and coagulation inhibitor assay). An in vitro Diagnostic Medical Device (IVD).
Recall of LIFECODES LifeScreen Deluxe (LMX). An in vitro diagnostic medical device (IVD).
Recall of ENA RELISA Single Well Screen (576 well) Kit. An in vitro diagnostic medical device (IVD)
Recall of LIFECODES HLA-C eRES SSO Typing Kit. An in vitro diagnostic medical device (IVD)
Recall of FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). An in vitro diagnostic medical device (IVD)
Recall of Pak Lx Assay
Recall of ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD).
Recall of Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 Typing Kit. An in vitro diagnostic medical device (IVD)
Recall of MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)
Recall of MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD)
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11 devices in the database
OriGen Syringe DMSO (Used for Research Use Only)
Model / Serial
OriGen Syringe DMSO (Used for Research Use Only)Multiple part numbers and lot numbers affected
PF4 IgG assay (Thrombophilia and coagulation inhibitor assay). An in vitro Diagnostic Medical Dev...
Model / Serial
PF4 IgG assay (Thrombophilia and coagulation inhibitor assay). An in vitro Diagnostic Medical Device (IVD).Lot Numbers: 3001992 & 3002227ARTG Number: 217308
LIFECODES LifeScreen Deluxe (LMX). An in vitro diagnostic medical device (IVD).
Model / Serial
LIFECODES LifeScreen Deluxe (LMX). An in vitro diagnostic medical device (IVD).Code Number: TL628215Lot Number: 3002350Expiration Date: 15 Nov 2015ARTG Number: 217870
ENA RELISA Single Well Screen (576 well) Kit. An in vitro diagnostic medical device (IVD)
Model / Serial
ENA RELISA Single Well Screen (576 well) Kit. An in vitro diagnostic medical device (IVD) Product Code: IC7696-10Lot Numbers:1525909 and 1525812 ARTG Number: 197980
LIFECODES HLA-C eRES SSO Typing Kit. An in vitro diagnostic medical device (IVD)
Model / Serial
LIFECODES HLA-C eRES SSO Typing Kit. An in vitro diagnostic medical device (IVD)Product Code: TL628921Lot Number: 10235BProbes affected: 380, 382, 384, 385ARTG Number: 217872
6 more
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