| TGA Action ID |
RC-2026-RN-00415-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
B·R·A·H·M·S KRYPTOR compact REACT. An in vitro diagnostic medical device (IVD)
Catalogue Number: CDB89986
Lot Numbers: 40102+R78, 40102+R79, 40102+R80 |
| ARTG Number |
190293 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Following the Product Alert (RC-2026-RN-00273-1) regarding observed quality control values outside the acceptable range at the lowest quality control level (QC Level 1) for the B·R·A·H·M·S PlGF Plus KRYPTOR test when performed on the B·R·A·H·M·S KRYPTOR compact PLUS analyser, further investigation has been completed.
The investigation determined that the previously reported underestimation of Quality Control Level 1 (QC1) is not attributable to the B·R·A·H·M·S PlGF Plus KRYPTOR reagent lots. Instead, specific lots of the B·R·A·H·M·S KRYPTOR compact REACT reaction plates have been identified as the root cause of the potential underestimation when B·R·A·H·M·S PlGF Plus KRYPTOR is performed on the B·R·A·H·M·S KRYPTOR compact PLUS analyser. |
| Instructions for Customers/Users |
Customers are to:
- Identify and cease use of the affected reaction plate lots (40102+R78, 40102+R79 and 40102+R80) when performing the B·R·A·H·M·S PlGF Plus KRYPTOR test (PN: 859075N; LN: 59171, 59177).
- Continue to use the reaction plates if operating the impacted device and not performing the B·R·A·H·M·S PlGF Plus KRYPTOR test.
- Follow the instructions in the customer letter to reconcile this recall. |
| Action Commencement Date |
3/06/2026 |
| Responsible Entity |
|
| Contact Information |
1300 735 292 - Customer Care Team |