| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00340-1 |
| Product Name/Description |
Amylase Assay used with ADVIA Chemistry Systems
Test Code: AMYLAS
Catalogue Numbers: 07498401 & 03031177
Siemens Material Numbers: 10309493 & 10341130
Lot Numbers: 304821 & 304816
Expiration Date: April 2015
ARTG number: 176331
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed that the affected Amylase reagent kit 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. The risk to health is limited to a potential delay in Amylase testing. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users that if a sample (u) flag occurs where there are no absorbance (U) flags, the flag is sample related and the sample should be re-tested. Siemens is advising users who choose not to continue using the affected batches, that Siemens will replace the affected lots. The look back of previously generated results is at the discretion of the laboratory. This action has been closed-out on 07/09/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |