Recall Z-0562-2021— Becton, Dickinson and Company, BD Biosciences
Class II · Terminated
Class II FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2020-10-05, terminated 2022-03-11. It names one FDA 510(k) clearance: K150815. Product: BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.. Reason: Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating..
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-05
- Terminated
- 2022-03-11
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.
Reason for recall
Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
Data sourced from openFDA. This site is unofficial and independent of the FDA.