Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00314-1
Product Name/Description ID-LISS/Coombs Cards. An in vitro diagnostic medical device (IVD)

Ref: 004017V

Lot Number: 50531.95.14 (Exp 30.06.2016)

Affected Box numbers: 5-1156-288 to 5-1156-318

ARTG number: 217697
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/04/2015
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue Unexpected reactions may rise in the 6th well of lot 50531.95.14 (exp. date 30/06/2016) product ID: ID-LISS Coombs cards reference 004017V (24 x 12 ID-Cards). Investigations have identified that a high level of 'broken gel' during a certain time period during filling and only a very limited quantity of ID-Cards are affected by this phenomenon of unexpected reaction in the 6th well.
Recall Action Recall
Recall Action Instructions To limit unexpected reactions, customers are asked to stop using the affected boxes (number between 5-1156-288 and 5-1156-318) and to destroy the remaining stock locally. Replacement unaffected stock will be sent.
Contact Information 1800 224 354 - Bio-Rad Laboratories