| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00256-1 |
| Product Name/Description |
Elecsys Thyroid Stimulating Hormone (TSH) and Elecsys Parathyroid Hormone (PTH) (1-84) when used on the cobas e 602 module. An in vitro diagnostic medical device (IVD).
Elecsys TSH
Material Number: 11731459122
Lot Number: 185522
Elecsys PTH (1-84)
Material Number: 05608546190
Lot Number: 185522
ARTG Number: 174907 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
An internal error resulted in assignment of the same lot number for Elecsys TSH reagents & Elecsys PTH (1-84) reagents. The number of tests and QC recovery of Elecsys TSH lot 185522 may be affected if the Elecsys PTH (1-84) lot 185522 was previously used on the same cobas e 602 module. The following may occur: a reduced number of determinations for Elecsys TSH assay (100 instead of 200 tests/kit); low recovery of Level 2 from PreciControl Universal (all lots) < -3 SD; and high recovery of PreciControl Thyro Sensitive & PreciControl TSH above +3 SD.
This issue could cause TSH results to appear above or below the normal ranges. It cannot be excluded that a delayed or incorrect diagnosis would not occur in certain high-risk patient populations where only TSH results are used e.g. in newborn screening or pre-interventional diagnostic scenarios, leading to inadequate or inappropriate treatments. No customer complaints regarding this issue have been received by Roche Diagnostics to date. |
| Recall Action |
Recall |
| Recall Action Instructions |
Roche is advising users to discontinue use of Elecsys TSH reagent lot 185522 on cobas e 602 modules that have previously used Elecsys PTH (1-84) reagent lot 185522. Replacement Elecsys TSH reagents will be provided. It is recommended that users discuss with their medical director whether a look-back is required for previously affected patient results. If hyperthyroidism is excluded based on TSH results only, patients whose results were generated from lot 185522 Elecsys TSH and in the range of 0.26 – 0.36 µIU/mL should be re-tested, especially if the patient’s clinical symptoms point to hyperthyroidism.
This action has been closed-out on 23/03/2018. |
| Contact Information |
02 9860 2357 - Roche Diagnostics Australia |