Recall Z-2237-2025 ยท GKZ Counter, Differential Cell
Becton, Dickinson and Company, BD Bio Sciences
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
| Date | Aug 1, 2025 (initiated Jul 8, 2025) |
| Status | Open, Classified |
| Reason | Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts. |
| Root cause | Labeling design |
| Action | On July 8, 2025, BD Biosciences issued a "Urgent: Medical Device Recall Correction" via mail. BD ask consignees to take the following actions: 1. Ensure the contents of this product notification are read and understood. 2. Share and post this customer letter with the users of this application at your facility and forward to any customers to whom you may have distributed the product to ensure awareness. 3. It is recommended that this notice be posted where these products are stored. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not |
| Quantity | 10 kits |
| Distribution | Worldwide - US Nationwide distribution in the states of Tennessee, New York, Massachusetts and the countries of Argentina, Belgium, Botswana, Brazil, Canada, France, Germany, Lithuania, Peru, Philippines, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.