| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00364-1 |
| Product Name/Description |
SYNCHRON Systems Lactate (LACT), An in vitro diagnostic medical device (IVD)
Reference: A95550
Lot Number: M206209
Expiry: 2013-04-30 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has received customer reports of suppressed LACT results for samples containing LACT concentration of 6.5 mmol/L or greater, when using the affected lot number. Internal testing confirmed that the issue for samples containing LACT concentrations between 9.2 and 11.0 mmol/L. Although these results are within the analytical range of 0.3 - 11.0 mmol/L, the results are suppressed and the system identifies the error condition RXN RATE HL. |
| Recall Action |
Recall |
| Recall Action Instructions |
Beckman Coulter is asking users to cease using the affected lot and is offering a replacement. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Service |