CLASS II ONGOING Device recall · Reported 8 Jun 2022 · FDA Enforcement Report
BD Anti-Kappa APC recalled by Becton, Dickinson and
Becton, Dickinson and Company, BD Biosciences is recalling BD Anti-Kappa APC (, distributed nationwide in the US. The recall was initiated on 25 Mar 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1214-2022
- FDA event ID
- 90028
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences, San Jose, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Mar 2022
- FDA classified
- 1 Jun 2022
- Reported
- 8 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 25 Mar 2022 | Recall initiated by company | |
| 1 Jun 2022 | Classified by FDA | +68 days |
| 8 Jun 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
Product as listed by the FDA
BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, DC, DE, FL, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, NC, ND, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and the country of Taiwan.
Nationwide AlabamaCaliforniaColoradoDistrict of ColumbiaDelawareFloridaIowaIllinoisIndianaLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouriNorth CarolinaNorth DakotaNew YorkOhio
Questions about this recall
Is BD Anti-Kappa APC ( recalled?
Yes. Becton, Dickinson and Company, BD Biosciences recalled BD Anti-Kappa APC ( on 25 Mar 2022. The recall is Class II and its status is Ongoing. Recall number Z-1214-2022.
Why was it recalled?
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
Which lots are affected?
Lot # 1064663; UDI: 00382903410989
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, DC, DE, FL, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, NC, ND, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and the country of Taiwan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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