BD Anti-Kappa PE Reagent Recall: Uncharacteristic Flow Profiles
BD Biosciences recalls Anti-Kappa PE reagent (Cat. No. 346587) due to uncharacteristic flow profiles that may affect flow cytometry results. Affected lots include 1228977.
Lower-risk recall
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
Contact the company
What happened, in plain English
BD Biosciences is recalling Anti-Kappa PE reagents (Cat. No. 346587) because they may show unusual flow patterns in flow cytometry tests. This could lead to inaccurate results in cell analysis. Read more at govinfonow.com/recall/60887-bd-anti-kappa-pe-reagent-recall-uncharacteristic-flow-profiles.
Source Summary by GovInfoNow · govinfonow.com/recall/60887-bd-anti-kappa-pe-reagent-recall-uncharacteristic-flow-profiles · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1215-2022
Cite this page
“BD Anti-Kappa PE Reagent Recall: Uncharacteristic Flow Profiles.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60887-bd-anti-kappa-pe-reagent-recall-uncharacteristic-flow-profiles. Based on FDA recall #Z-1215-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1215-2022%22&limit=1).
Why it’s dangerous
The reagents may show uncharacteristic flow profiles during flow cytometry testing, which could cause inaccurate cell analysis results. This is a technical issue that might affect the reliability of the test outcomes.
Who’s affected
Researchers and lab technicians using flow cytometry who have the specific reagent lot 1228977 are affected. Those conducting cell analysis with this reagent are most at risk.
How to tell if you have this one
Check for the lot number 1228977 on the reagent packaging. The product is identified by the unique identifier 00382903465873 and catalog number 346587.
- Brand
BD Biosciences- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1214-2022 | 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.; Lot # 1064663; UDI: 00382903410989 | 249 units |
| Z-1215-2022 | BD Anti-Kappa PE (Cat. No. 346587) 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.; Lot # 1228977; UDI: 00382903465873 | 199 units |
What to do — step by step
Check Reagent Lot Number
Look for the lot number 1228977 on the reagent packaging to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 28 states.
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, Delaware, District of Columbia, Florida, Illinois, Indiana, Iowa, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1215-2022 (March 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1215-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.