| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01413-1 |
| Product Name/Description |
Spot-light Tissue Pre-treatment Kit (Antigen retrieval reagent used in cellular imaging). An in vitro diagnostic medical device (IVD).
Catalogue Number: 008401
Lot Numbers: 1667961A (exp. 31 Jul 2016), 1713166A (exp. 30 Nov 2016), 1714439A (exp. 30 Apr 2017), 1763308A (exp. 28 Feb 2018)
ARTG Number: 212745 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
1/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that the enzyme digestion reagent (Reagent 2) contains 1.3X the normal amount of enzyme (pepsin) leading to excessive pepsinisation of cells. This may cause loss of tumour cell morphology and inadequate hybridization of FISH/CISH probes. The over pepsinisation will be obvious to the user when examining slides under a microscope. |
| Recall Action |
Recall |
| Recall Action Instructions |
Life Technologies is advising users to dispose of affected stock. Credit will be issued for the affected stock. Unaffected stock is expected to be available from 31 November 2016. This action has been closed-out on 18/05/2017. |
| Contact Information |
1800 636 327 - Life Technologies Australia |