Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19802 |
| Brand Name: | Siemens Dimension Blood Urea Nitrogen (BUN) Flex Reagent Cartridge |
| Model: | K1021 |
| Affected: | Lot Nos: 15215AE 15243BB 15264BA 15299BB 15300BA 1532OBB 15341AC |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd 55 Hugo Johnston Drive Penrose Auckland |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Healthcare Diagnostics (UK) Ltd |
| Issue: | The manufacturer has determined that Dimension Vista® Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA, 15320BB, and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex® reagent cartridges manufactured from specific mold cavities. Investigation indicates loss of activity of the GLDH reagent wells from specific mold/cavity identifiers. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 26/2/2016 |
