| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01481-1 |
| Product Name/Description |
Pipet Tips used with AutoDG System. An in vitro diagnostic medical device
Product Number: 1864120, 1864121, 12003010
Lot Numbers: PR136933, PR137957, PR138863, PR139939, PR136556, PR136109, PR134751, PR135656, PR135220
ARTG Number: 296086 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
This failure appears as low total volume in the well of the AutoDG droplet plate after automated droplet generation, and results in low droplet counts when analyzing data in QuantaSoft. The failure is most frequently observed in columns 2 and 8 of the droplet plate, which corresponds to the fourth column of pipet tips in each box (when loaded with the box label facing front).
This issue may impact pipet tip lots shipped in 2017 and is most frequently observed with pipet tips from column 4 of the pipet tip box.
This defect has no safety or efficacy impact, and will not result in erroneous results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bio-Rad has decided to continue to ship pipet tips with a short-term workaround detailed in the Customer Letter.
This action has been closed out on 7/09/2018. |
| Contact Information |
1800 224 354 - Bio-Rad Technical Support |