| TGA Action ID |
RC-2025-RN-00522-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
BD FACS 7-Color Setup Beads. An in vitro diagnostic medical device (IVD).
Catalog number: 335775
Lot numbers: 85612, 85613
Expiry date: Sept 2025 |
| ARTG Number |
197669 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Based on customer feedback, BD identified errors in the spectral overlap factors table provided with specific lots of BD FACS 7-Color Setup Beads.
This problem may affect the accuracy of flow cytometry data due to incorrect flow cytometry setup compensation values for multi-color reagents for which proper fluorescence compensation is essential prior to sample analysis.
This problem compromises the accurate setup of the flow cytometry instrument when using multi-color reagents, potentially leading to erroneous results, delays in obtaining results and possible impacts on health care management decisions. In some cases, subjects may be required to return for an additional sample collection.
As of the current date, no adverse events associated with this problem have been reported globally. |
| Instructions for Customers/Users |
Customers are to note that:
· Table 1 in the customer letter provides the corrected Spectral Overlap Factors (SOF) values for the affected product lot numbers. The correct SOF values must be manually entered as per the instructions in Attachment 1.
· Who have not used the affected product may proceed to enter the SOF values shown in Table 1 in the customer letter.
· If the affected products have been fully or partially used and subjects' samples were processed using incorrect SOF values, please review the results.
- If the subjects’ sample are available, after entering the correct SOF values in the flow cytometry instrument, reacquire the sample(s).
- If the subject sample(s) is not available anymore, this may require the subject to return to collect an additional sample for testing purposes.
· Those who have previously used the affected product must discard any old label inserts containing incorrect SOF values and carefully follow the instructions in Attachment 1 to ensure accurate manual entry of the corrected SOF value.
This action has been closed out on 17/10/2025. |
| Action Commencement Date |
4/06/2025 |
| Responsible Entity |
|
| Contact Information |
1800 656 100 - Becton Dickinson |