Recall Z-0171-2023 ยท GKZ Counter, Differential Cell
Becton, Dickinson and Company, BD Biosciences
BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.
| Date | Nov 3, 2022 (initiated Oct 3, 2022) |
| Status | Open, Classified |
| Reason | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier. |
| Root cause | Under Investigation by firm |
| Action | On 10/03/2022, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter via FedEx tracked letters and emails informing customers, through internal investigations, the labels applied to the BD Trucount tubes are becoming detached due to an adhesive change made at a supplier. Customers are instructed to: 1. Immediately review their inventory for the specific catalog and lot numbers. 2. For any tubes where label detachment is observed, BD recommends that the clinician remove the label from the tube and, using a permanent marker, record the tube lot number as well as any other relevant informat |
| Quantity | 52,570 tubes (corrected on 11/04/2022) |
| Distribution | U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, and WI O.U.S.: Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090967 | BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 Bd Biosciences, Jul 31, 2009 |