| 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 |
|
| 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 |