Recall Z-2598-2018 ยท OYE Flow Cytometric Reagents And Accessories.
Becton, Dickinson and Company, BD Biosciences
BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and 40-tube racks. A barcode reader verifies the ID on tube racks and individual tube
| Date | Jul 13, 2018 (initiated May 16, 2018) |
| Status | Terminated |
| Reason | The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, BD Life Sciences, produced the "URGENT PRODUCT RECALL-CORRECTION" letter dated 4/6/2018 to its customers during an on-site visit. by the field service engineer made beginning 5/16/2018 to correct the issue. The visits were completed 6/15/2018. If you require further assistance, contact BD Customer/Technical Support BD Customer Support at 877.232.8995 (prompt 2) for instruments in the United States. For customers outside the US, contact your local BD representative or distributor. |
| Quantity | 8 devices |
| Distribution | US Distribution was made to FL, KS, KY, MA, NJ, and SD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multit Becton, Dickinson and Company, Jul 3, 2017 |