| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00101-1 |
| Product Name/Description |
Phadia AB Product EliA anti-TSH-R Well. An in vitro diagnostic medical device (IVD)
Lot Number: 0014
Abacus ALS Part Number: PU14563901
Manufacturers Part Number: 14-5639-01
ARTG Number: 229585
(Abacus ALS Pty Ltd - Clinical chemistry autoimmune IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
2/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
A malfunction of EliA anti-TSH-R Well Carriers 14-5639-01 in lot 0014 has been discovered. The specified lot includes a limited number of carriers, where 8 or 16 Wells in sequence will produce decreased response units (RU). Out of 4122 carriers, to date 12 carriers have been identified giving this low RU pattern.
To date, no adverse events have been reported. In Australia these kits are currently used for evaluation purposes, not for generating patient results.
This recall does not affect any other lots of EliA anti-TSH-R or any other Phadia products. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abacus ALS is advising affected users to quarantine any affected stock of the specified lot and discontinue use.
This action has been closed out on the 22/11/2018. |
| Contact Information |
1800 222 287 - Customer Service Support |