Type of Product |
Medical Device |
TGA Recall Reference |
RC-2013-RN-00841-1 |
Product Name/Description |
Liquichek Sedimentation Rate Control, Level 2. An in vitro diagnostic medical device (IVD)
Lot Number: 13972
Catalogue Numbers: 515, 514X MiniPak |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
12/08/2013 |
Responsible Entity |
|
Reason/Issue |
Bio-Rad has confirmed that erythrocyte sedimentation rate (ESR) values of Liquichek Sedimentation Rate Control, Level 2, Lot No. 13972 have decreased and may no longer be within established ranges. |
Recall Action |
Recall |
Recall Action Instructions |
Bio-Rad is requesting users to discontinue and discard any remaining inventory of this lot of Liquichek Sedimentation Rate Control. Affected units will be replaced by Bio-Rad. |
Contact Information |
1800 224 354 - Bio-Rad Laboratories |