Becton, Dickinson and Company, BD Biosciences recall records

7 reported ongoing

7 records in this archive. Latest source date May 8, 2024.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166; BD Multitest 6-Color TBNK, IVD, REF: 662967; BD Multites...

Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive event increase on CD3+CD4+vsCD3+CD8+ and/or CD3-CD16+CD56+v...

Class IIReported ongoing

Distribution: US: MN, NJ, NY, MD, UT, FL, NC, MA, KY, NE, NV, CA, LA, DC, OH, MI, PA, WA, CT, AL, DE, TN, IN, OR, IL, WI, NH, TX, GA, RI, SD, ID, NM, AR. OUS: CA, SG, NZ, AU, KR, IN, PE, GT, ...

Official source for BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tub...
FDA device enforcement

CD11b APC: ASR, REF: 340936, and CE, REF: 333143

In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional ...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of IL, MN, FL, MI, MD, NC, NY, CA, GA, AR, KS, PA, NH, TX, OK, MA, MO, DC, AZ, IN, NJ, TN, WA, VA, CT and the coun...

Official source for CD11b APC: ASR, REF: 340936, and CE, REF: 333143
FDA device enforcement

BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such a...

Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due ...

Class IIReported ongoing

Distribution: U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, and...

Official source for BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood....
FDA device enforcement

BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are designed for use with in vitro diagnostic products such a...

Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due ...

Class IIReported ongoing

Distribution: U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, and...

Official source for BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood....
FDA device enforcement

BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percen...

Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.

Class IIReported ongoing

Distribution: U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, and...

Official source for BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACS...
FDA device enforcement

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. An...

Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.

Class IIReported 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, ...

Official source for BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, w...
FDA device enforcement

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. Ant...

Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.

Class IIReported 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, ...

Official source for BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, wh...

Reasons in these listed records

  • Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive event increase on CD3+CD4+vsCD3+CD8+ and/or CD3-CD16+CD56+vsCD3-CD19+, contamin...
  • In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.
  • Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive chang...
  • Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.

These examples come from this result page and are not a ranking of every recall reason.

Checking Becton, Dickinson and Company, BD Biosciences

Is there a recall on becton, dickinson and company, bd biosciences right now?

This archive contains 7 records, including 7 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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