| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01270-1 |
| Product Name/Description |
Quantum Blue Calprotectin Assay and Quantum Blue Calprotectin High Range
Quantum Blue Calprotectin Assay
Lot Numbers: 2930N
Expiry: 2017-July-31
Quantum Blue Calprotectin High Range
Lot Number: 2930N.HR
Expiry: 2017-April-30 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
A typographical error has been identified in certain Quantum Blue Calprotectin Assay Kits. The printed expiration date on the labelling of the kits is incorrect.
The correct expiry date is 2016-Dec-31. There is no risk to health if the assay kits are used by this date. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Taylor Biomedical has advised customers to check if they have affected stock. Customers will be requested to include in the affected stock, an advisory notice with details of the correct expiry date.
This action has been closed-out on 28/11/2016. |
| Contact Information |
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