Recall Z-2358-2020— Becton, Dickinson and Company, BD Biosciences

Name: FDA recall Z-2358-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-08

Class II · Terminated

Class II FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2019-07-08, terminated 2023-01-31. It names one FDA 510(k) clearance: K131301. Product: BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II and BD FACSCalibur flow cytometry systems. Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto II flow cytometry systems. Reason: The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense..

Recalling firm: Becton, Dickinson and Company, BD Biosciences
Classification: Class II
Status: Terminated
Initiated: 2019-07-08
Terminated: 2023-01-31
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K131301 — BD FACS SAMPLE PREP ASSISTANT IIIBecton, Dickinson & CO·cleared 2013-08-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II and BD FACSCalibur flow cytometry systems. Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto II flow cytometry systems

Reason for recall

The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.

Data sourced from openFDA. This site is unofficial and independent of the FDA.