| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01623-1 |
| Product Name/Description |
PreciControl Varia when used with Elecsys Parathyroid Hormone (PTH) assay on the cobas e 411 analyser. An in vitro diagnostic medical device (IVD).
PreciControl Varia
Material Number: 05618860190
Lot Number: 18928501
Elecsys PTH assay
Material Number: 11972103122
Lot Number: 185000, 143251
ARTG Number: 216332 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
The barcode and value sheet for a single lot of PreciControl Varia contain an erroneous target value for control level 2, when used with certain lots of Elecsys PTH assay on cobas e 411 analyser. The deviation between the correct & erroneous value is 20% for PTH lot 185000 & 31% for PTH lot 143251. This issue can be detected because it will cause elevated level 2 control recoveries. Also it can be detected if both control levels 1 & 2 are run prior to measurement of patient samples.
If only control level 2 is used and a local issue occurs in the lab where false-low PTH results of -20% to -31% are obtained, the control would be within range and consequently false-low results could be reported. In an intra-operative measurement scenario, an erroneous low PTH result can result in an incorrect conclusion that tumour resection was complete. In the worst case, remaining cancerous or hyperplastic tissue may be left undetected.
To date, no customer complaints have been received by Roche. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche is providing users with the correct control level 2 target values for the PTH assay on an updated value sheet. The correct target value is to be manually entered by the user, noting there is a reagent lot-specific value for Elecsys PTH lot 143251 and for other lots the PTH value target value should be used as per routine operation. This action has been closed-out on 25/05/2017 |
| Contact Information |
02 9860 2357 - Roche Diagnostics Australia |