| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00149-1 |
| Product Name/Description |
KWIK-QC Acid Fast Stain Slides (Microbiology quality control slides). An in vitro diagnostic medical device (IVD)
Product Code: SL42-10
Lot Number: 4242
Expiry Date: 20/06/2014 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
Control organisms are not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abacus ALS is requesting customers supplied with the affected lot to destroy all remaining stock. Abacus will arrange for replacement with unaffected stock. |
| Contact Information |
07 3391 9777 - Abacus ALS Technical Services |