| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00401-1 |
| Product Name/Description |
Immulite 2000 and Immulite 2000 XPi – Italian Cypress Allergen
Siemens Material Number: 10386079
Lot Numbers: 206 and 208
ARTG number: 198420 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed that the IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen lot 206 does not meet the shelf-life stability as indicated on the label. This may lead to single class change decrease (standard classification) in patient results across the current shelf-life of this allergen lot. Patient dose values may decrease before the stated expiry date listed on the allergen vial.
It is expected that lot 208 will also not meet its current shelf life stability and must be discarded after June 30, 2015. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is requesting laboratories to discard IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen from lot 206. The shelf-life of IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 208, has been shortened to June 30, 2015. Laboratories are requested to discontinue use and discard lot 208 after June 30, 2015. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |