| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00690-1 |
| Product Name/Description |
Product-CD30 (Ber-H2)
Incorrect Primary Antibody Expiration Dating
Affected lot numbers: D04835Z, D09123, E00209, E03668, E04391, E05896
ARTG Number: 175635 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
28/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
Ventana Medical Systems, Inc. (Ventana) would like to inform you that the expiration date of the VENTANA CD30 (Ber-H2) Mouse Monoclonal Primary Antibody (Part Number 790-4858, Roche Material Number 07007841001) was inadvertently labelled with a 24 month expiration date for the referenced lot numbers. Based on extensive testing of the affected lots, Ventana can only support an 18 month expiration date. |
| Recall Action |
Recall |
| Recall Action Instructions |
Roche is requesting their customers to stop use of the affected product. Roche is also recommending that any clinical cases tested after the actual expiration date be re-tested in accordance with your local laboratory practices and policies, especially if tissue and/or same-slide controls were not performed in association with the original case. This action has been closed-out on 05/09/2016. |
| Contact Information |
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