| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00537-1 |
| Product Name/Description |
cCrea A+B Membranes used with ABL800 series blood gas analyser range
Item # 942-073, 08088 Crea A + 08089 Crea B membran
Lot Numbers: 557 onwards
ARTG Number: 229300 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
In November 2014, Radiometer Pacific notified customers (TGA Ref: RC-2014-RN-01201-I) that the cCrea results for QC decrease to below the lower acceptance limit within the lifetime of the Crea membranes. The corrective action implemented at that time was to perform one quality control measurement every 24 hours using S7835 AutoCheck 6+, level 1 (944-094) to verify the cCrea performance. If the QC result was out of range, new Crea A and Crea B membranes had to be installed.
Radiometer has now resolved the problem (starting with Lot 557 and onwards) with narrowed specifications for the membrane material to reduce the diffusion rate through the membrane and has verified that the change brings the performance (drift and lifetime) back to the previous level. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
For membrane units below Lot 557:
Continue to perform one quality control measurement every 24 hours using S7835 AutoCheck 6+, level 1 to verify the cCrea performance. If the QC result is out of range, new Crea A and Crea B membranes must be installed.
Alternatively, if you wish to return any remaining unused units of cCrea membrane from Lots below 557 please contact your local Radiometer Account Manager on 1800 247 254.
For membrane units of Lot 557 onwards:
You may return to your standard practice for running QC for the cCrea membranes. This action has been closed-out on 17/08/2016. |
| Contact Information |
1800 247 254 - Radiometer |