| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01199-1 |
| Product Name/Description |
Clinical Chemistry Phenobarbital Reagent. An in vitro diagnostic medical device (IVD)
List Number: 1E08
Lot Numbers: 52803UN12 (expired), 62299UN12 & 85773UN12
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Diagnostics is recalling this product due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital is 'less than or equal to' 7% Total CV%. Internal testing has confirmed CVs up to approximately 12% for in-date reagent lots over five months old. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abbott is asking users to discontinue use and dispose of the affected units. |
| Contact Information |
1800 816 696 - Abbott Customer Support |