| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00884-1 |
| Product Name/Description |
Sorenson’s Buffer. An in vitro diagnostic medical device (IVD)
Product Codes: FNNGG029 and FNNGG030
Affected Lot Numbers: 1603216780, 1506195360, 1508200130, 1509202540, 1509203020 and 1510206300
ARTG Number: 244172 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
7/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
There are three deficiencies in the current labelling of Sorenson’s buffer (pH 6.8 and 7.2). The labels are: 1) missing the dilution instructions, 2) have the incorrect spelling of Sorenson’s and 3) do not clearly describe the product as concentrated.
Thermo Fisher Scientific has confirmed that the product, apart from the labelling, has not changed in any way. In the event of the product being used undiluted, there is minimal pH variation between the concentrated and diluted solutions (0.2 units) and consequently, no to minimal risk on performance. The corrected label has been applied to all stock on hand at Thermo Fisher Scientific to include the concentration and dilution instructions.
The corrected label has been applied to all stock on hand at Thermo Fisher Scientific to include the concentration and dilution instructions. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Thermo Fisher Scientific is providing users with the correct labels and advising that the correct dilution factor is 1 in 10 diluted with deionised water. |
| Contact Information |
02 8817 4279 - Thermo Fisher Scientific |