Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18384 |
| Brand Name: | Siemens ADVIA Chemistry Systems, Amylase |
| Model: | Catalogue Numbers: 07498401 & 03031177 |
| Affected: | Lot Numbers: 304821 & 304816, Expiry Apr-2015 |
| 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: | Siemens Healthcare Diagnostics has confirmed that Amylase reagent kit lots 304821 and 304816 for use on the ADVIA® 1200, 1650, 1800 and 2400 Chemistry Systems demonstrate an increased incidence of absorbance flags (U or U accompanied by u). Absorbance flags (U) indicate an abnormally high reagent blank absorbance exceeding the reagent blank limit. In some cases with these reagent lots, sample results may also have a Sample Absorbance (u) flag indicating a high absorbance for the sample that occurs in conjunction with the (U) flag. Amylase results can be generated with these flags. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/4/2015 |
