| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01318-1 |
| Product Name/Description |
VITROS Immunodiagnostic Products Intact iPTH Reagent Packs & Calibrators (used on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems, &
VITROS 5600 Integrated Systems) An in vitro diagnostic medical device (IVD)
Intact PTH Reagent Pack
Product Code: 6802892
Lot Numbers: 0700 (exp.18-10-16), 0710 (exp. 14-11-16), 0748 (exp. 6-2-17), 0758 (exp. 6-3-17)
Intact PTH Calibrators
Product Code: 6802893
Lot Numbers: 0728 (exp.12-12-16), 0738 (exp. 2-1-17), 0768 (exp.10-4-17)
ARTG number: 176641 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that results obtained from VITROS Intact Parathyroid Hormone (iPTH) Reagent Packs are positively biased (i.e. falsely elevated) compared to an alternative commercially available method. Ortho observed a positive bias of 40% for samples with iPTH concentrations <100pg/mL when testing with VITROS iPTH Reagent Packs. This bias is consistent for all in-date lots. Due to this positive bias, samples from patients with normal levels of iPTH may be above the current reference interval. Therefore, the reference interval as defined in the Instructions for Use (7. 5-53.5 pg/mL (0.8-5.7 pmol/L)) is no longer supported. The lot in which the bias originated has not been identified, so this issue affects all in-date lots and potentially lots that have expired.
Due to limited availability of samples with iPTH concentrations >100 pg/mL, Ortho's root cause investigation of the issue is ongoing. |
| Recall Action |
Recall |
| Recall Action Instructions |
Ortho is advising users to immediately stop performing the VITROS Intact PTH test using VITROS Intact iPTH Reagent Packs and Calibrators, and discard Reagent Packs and Calibrators from the affected lot numbers. Ortho will issue credit for discarded lots. For results previously generated using the known affected lots, any concerns should be discussed with the Laboratory Director. For results obtained with other lots that have expired, a review of previous results may be impractical as the lot in which the bias originated has not been identified.
This action has been closed-out on 28/02/2018. |
| Contact Information |
1800 032 359 - Ortho Care Technical Solutions Centre |