| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00676-1 |
| Product Name/Description |
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent. An in vitro diagnostic medical device (IVD)
IGM reagent cartridge: 1 x 15.2 mL
IGM compartment A: 7.6 mL
IGM compartment B: 7.6 mL
Reference number: 447610
Lot numbers: M307362, M309410
Expiry dates: 31May2025, 31Jul2025
ARTG 213974
(Beckman Coulter Australia Pty Ltd - Clinical chemistry enzyme IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
IMMAGE Immunochemistry Systems IGM Immunoglobulin M reagent lots M307362 and M309410 are not meeting the sensitivity statement in the IFU:
“Sensitivity is defined as the lowest measurable concentration which can be distinguished from zero with 95% confidence. Sensitivity for IGM determination is 4.2 mg/dL.” |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should:
- Discontinue use of affected IMMAGE Immunochemistry Systems IGM Immunoglobulin M reagent lots
- Review the Safety Data Sheet (SDS) and discard according to their laboratory’s Standard Operating Procedures and/or local regulations. The SDS is available on www.beckmancoulter.com
- Contact Beckman Coulter Customer Support Centre or their local Beckman Coulter representative to organise replacement stock |
| Contact Information |
1800 060 881 - Customer Support Centre |