Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21294 |
| Brand Name: | Dimension EXL Troponin I & Dimension Vista Digoxin, Estradiol, Ferritin, Prolactin and Thyroid Stimulating Hormone |
| Model: | Thyroid Stimulating Hormone (TSHL), LOCI Free Thyroxine (FT4L), Thyroid Stimulating Hormone (TSH), Cardiac Troponin I (CTNI), Mass creatine kinase MB isoenzyme (MMB), Sirolimus (SIRO), All lots (including all future lots until Instructions For Use update) |
| Affected: | DM Troponin I (TNI), DV Digoxin (DIGXN), DV Estradiol (E2), DV Ferritin (FERR), DV Prolactin (PRL), DV Thyroid Stimulating Hormone (TSH) All lots including all future lots until instructions of use is updated |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd Millennium Centre, Part Level 2, Building A 600 Great South Road Ellerslie AUCKLAND 1051 |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Healthcare Diagnostics Inc |
| Issue: | Update 23 October 2017 to March 2017 Urgent Recall for Product Correction regarding incorrect units for biotin listed in the Non-Interfering Substances section of select Instructions for Use in Dimension® and Dimension Vista® assays. Ongoing investigation has identified the following new information regarding biotin interference: 1. Biotin interference limits are incorrectly listed in the Instructions for Use (IFU) for the following assays: Dimension TSHL, Dimension FT4L and Dimension Vista TSH. Concentrations of biotin above the concentration listed in Table 2 in the Revised Biotin Non-Interference column can potentially result in interference >10%. 2. The Dimension Vista CTNI, MMB, and Dimension SIRO method IFUs do not contain biotin interference information. Concentrations of biotin above the concentration in the Revised Biotin Non-Interference column can potentially result in interference >10%. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 24/10/2017 |
