| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01108-1 |
| Product Name/Description |
Red top histology jars containing 10% Neutral Buffered Formalin Solution. An in vitro diagnostic medical device (IVD)
Code: FNNNBF/30CAPITAL
Batch Numbers: 1508201420, 1508201420, 1606220560
ARTG Number: 243713 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
22/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Investigations by Thermo Fisher Scientific have confirmed that an error in jar labelling has occurred in certain lots of Red top histology jars (with formalin) for tissue specimens.
Correct label:
“Tissue Specimen” “POISON – Contains 10% Buffered Formalin”
Incorrect label:
“Specimen Container For Urine, Sputum, Semen, etc” Poison statement missing |
| Recall Action |
Recall |
| Recall Action Instructions |
Thermo Fisher is advising users to inspect stock and return the affected stock for replacement with unaffected product. This action has been closed-out on 15/02/2017. |
| Contact Information |
02 8817 4279 - Thermo Fisher |