| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00369-1 |
| Product Name/Description |
G-6-PDH Control Kits, Normal. An in vitro diagnostic medical device (IVD)
Product Code: G6888
Lot Numbers: 035, 036, 037 & 038
Expiration Date: 2013-12 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Following an investigation of customer complaints, the affected lot numbers have been found to have poor stability following reconstitution. It has been confirmed that the reconstituted control does not maintain the full 7 day stability when stored at 2-8degC as stated in the package insert. The Control may recover within range on day 1 after reconstitution, but will fall out of range before reaching 7 days.
This recall action was carried out prior to approval of the recall strategy by the TGA. |
| Recall Action |
Recall |
| Recall Action Instructions |
Immuno is advising users to discontinue use of the affected lots, and destroy remaining stock. Affected stock will be replaced by Immuno. |
| Contact Information |
02 9519 9300 - Immuno |