Recall Z-0173-2023
Becton, Dickinson and Company, BD Biosciences · initiated October 3, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.
Codes / lots: Corrected as of 11/04/2022: Catalog Number: 662995 UDI-DI Code: 00382906629951 Lot Numbers: 11568 45905 53637 88003 89111 31905
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
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 information directly on the tube. Removal of the label prevents it from interfering with any auto-loading sample preparation and analysis systems, as well as from sticking to other tubes. For questions, contact North American Regional Complaint Center at: Phone: 1-844-8BD-LIFE (1-844-823-5433), Say "Recall" when prompted Mon-Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
Details
- Recall number
- Z-0173-2023
- Initiated
- October 3, 2022
- Posted by FDA
- November 3, 2022
- Product code
- GKZ – Counter, Differential Cell
- Quantity
- 1,457 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 Republic, Ecuador, El Salvador, Guatemala, Hong Kong, India, Japan, Korea, Mexico, Malaysia, New Zealand…
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences, San Jose, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0171-2023 Class II | BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes…Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or… | 10/03/2022Open, Classified |
| Z-0172-2023 Class II | BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes…Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or… | 10/03/2022Open, Classified |