Recall Z-0562-2021 ยท JPK Mixture, Hematology Quality Control
Becton, Dickinson and Company, BD Biosciences
BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.
| Date | Oct 5, 2020 |
| Status | Terminated |
| Reason | Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating. |
| Root cause | Process control |
| Action | On 10/13/2020, the firm notified it customer via telephone and sent an "URGENT MEDICAL DEVICE RECALL" Notification via email and/or FedEx to inform them that complaints have been report regarding their Low Control product which shows an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate gating with the potential for delayed patient management. Customer are instructed to: 1. Immediately review their inventory for the specific Catalog and lot numbers listed. Destroy all product subject to this recall following their institutions process for destruction. 2. Sh |
| Quantity | 619 vials |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, NC, NJ, NV, NY, OH, OK, PA, PR, RI, SD, TN, TX, and VA. The countries of Canada, Belgium, Korea, India, Ecuador, Japan, Costa Rica, Australia, Vietnam, Pakistan, Singapo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150815 | BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit Becton, Dickinson and Company, Dec 17, 2015 |