Home / Recalls / Becton, Dickinson and Company, BD Biosciences / Z-2333-2021

Z-2333-2021 Class II Terminated

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

FDA device recall Z-2333-2021 was initiated by Becton, Dickinson and Company, BD Biosciences on July 22, 2021 and is designated Class II. Reason for recall: Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive stain… The recall status is terminated (terminated March 24, 2023). Affected quantity: 23 reagents.

Recall Details

Product Type
Devices
Report Date
September 1, 2021
Initiation Date
July 22, 2021
Termination Date
March 24, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23 reagents

Product Description

BD" Mouse IgG2a Isotype Control APC X39 ASR

Reason for Recall

Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another antibody.

Distribution Pattern

Worldwide distribution - U.S. Nationwide distribution in the states of CT, FL, KY, NY, and PA. The country of Taiwan.

Code Information

Catalog Number: 340757 UDI: 00382903407576 Lot Number: 0253432

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-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)
  • Z-0072-2020 Class II — BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using (August 19, 2019)

FDA data resources