Home / Recalls / Becton, Dickinson and Company, BD Biosciences / Z-2598-2018

Z-2598-2018 Class III Terminated

Recalled by Becton, Dickinson and Company, BD Biosciences — San Jose, CA

Recall Details

Product Type
Devices
Report Date
August 8, 2018
Initiation Date
May 16, 2018
Termination Date
August 13, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8 devices

Product Description

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 tubes in 30- tube racks. A built-in imaging system provides safety checks, such as verifying the correct rack type and tube layout, and ensures the tubes were loaded correctly.

Reason for Recall

The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.

Distribution Pattern

US Distribution was made to FL, KS, KY, MA, NJ, and SD.

Code Information

Serial #2662879000001, UDI (01)00382906628794(11)170915(21)Z662879000001; Serial #2662879000002, UDI (01)00382906628794(11)170915(21)Z662879000002; Serial #2662879000003, UDI (01)00382906628794(11)170915(21)Z662879000003; Serial #2662879000004, UDI (01)00382906628794(11)170915(21)Z662879000004; Serial #2662879000009, UDI (01)00382906628794(11)170915(21)Z662879000009; Serial #2662879000010; UDI (01)00382906628794(11 )170915(21)Z662879000010; Serial #2662879000011; UDI (01)00382906628794(11)170915(21)Z662879000011; and Serial #2662879000012, UDI (01)00382906628794(11)170915(21)Z662879000012.

Other recalls by Becton, Dickinson and Company, BD Biosciences

  • Z-2351-2024 Class II — BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit wi (May 8, 2024)
  • Z-0641-2024 Class II — CD11b APC: ASR, REF: 340936, and CE, REF: 333143 (October 25, 2023)
  • Z-0171-2023 Class II — BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leu (October 3, 2022)
  • Z-0172-2023 Class II — BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leu (October 3, 2022)
  • Z-0173-2023 Class II — BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for (October 3, 2022)
  • Z-1215-2022 Class II — BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-K (March 25, 2022)
  • Z-1214-2022 Class II — BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti- (March 25, 2022)
  • Z-2333-2021 Class II — BD" Mouse IgG2a Isotype Control APC X39 ASR (July 22, 2021)
  • Z-0562-2021 Class II — BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a comple (October 5, 2020)
  • Z-1971-2020 Class II — Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-11 (March 31, 2020)