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Lower risk Medical device recall · FDA · Published October 3, 2022

BD Multitest 6-Color TBNK Recall: Partial Label Detachment Causes Automation Errors

BD Biosciences recalls BD Multitest 6-Color TBNK with optional Trucount Tubes (Cat. No. 662995) due to partial label detachment that can cause tubes to stick together or automation errors in flow cytometers.

🇺🇸 FDA recall #Z-0173-2023Medical deviceBD Biosciences ›
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Recalling firmBecton, Dickinson and Company, BD Biosciences2350 Qume Dr · San Jose, CA 95131-1812
✎ GovInfoNow plain-language explainer

BD Biosciences is recalling BD Multitest 6-Color TBNK with optional Trucount Tubes (Cat. No. 662995) because partial label detachment may cause tubes to become stuck together or lead to automation errors when used with flow cytometers. This could affect lab results and require corrective action. Read more at govinfonow.com/recall/59962-bd-multitest-6-color-tbnk-recall-partial-label-detachment-causes.

Source Summary by GovInfoNow · govinfonow.com/recall/59962-bd-multitest-6-color-tbnk-recall-partial-label-detachment-causes · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0173-2023

Cite this page

“BD Multitest 6-Color TBNK Recall: Partial Label Detachment Causes Automation Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59962-bd-multitest-6-color-tbnk-recall-partial-label-detachment-causes. Based on FDA recall #Z-0173-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0173-2023%22&limit=1).

The FDA announced on October 3, 2022, that BD Biosciences is recalling BD Multitest 6-Color TBNK tubes due to partial label detachment. This defect can cause tubes to stick together or trigger automation errors in compatible flow cytometers.

How to tell if you have it

  • Brand: BD Biosciences
  • Product: BD Multitest 6-Color TBNK with optional BD Trucount Tubes
  • Catalog Number: 662995
  • Lot Numbers: 11568, 45905, 53637, 88003, 89111, 31905

The hazard

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

Context

GovInfoNow's records show Becton, Dickinson and Company, BD Biosciences has 10 other recalls on record since May 16, 2018. Other recent recalls of similar products include BD Multitest 6-Color TBNK Kit (May 8, 2024), BD Biosciences CD11b APC (October 25, 2023), and BD Anti-Kappa APC Reagent Recall (March 25, 2022). Other recent recalls of similar products include Stryker FluidSmart Urology Tube Set (April 9, 2026), Beckman Coulter CellMek SPS Sample Prep System Software Error Risk (December 23, 2025), and Copan Italia DTT Liquid Reagent Recall (October 29, 2025).

How to tell if you have this one

Check for BD Multitest 6-Color TBNK with optional Trucount Tubes (Cat. No. 662995) sold for BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers. Lot numbers 11568, 45905, 53637, 88003, 89111, and 31905 are affected.

  • Brand
    BD Biosciences
  • Category
    Medical device
FDA recall event · 3 products

All 3 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
    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 WI O.U.S.: Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Hong Kong, India, Japan, Korea, Mexico, Malaysia, New Zealand, Panama, Peru, Philippines, Paraguay, Singapore, Thailand, Taiwan, and Uruguay
Recall numberProduct, codes & lotsQuantity
Z-0171-2023BD 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 as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.; Added/Corrected as of 11/04/2022: Catalog Number: 340334 UDI-DI Code: 00382903403349 Lot Numbers: 2031144 2034642 2035110 2035121 2060660 2073297 2073298 2095186 2101458 2108676 2112862 2152055 2152064 2152068 2152075 2152080 2203024 2208091 2215812 2235269 2223229 2236782 2236934 2236936 2236937 2236783 2237006 2237008 2237012 2237014 2237015 223701652,570 tubes (corrected on 11/04/2022)
Z-0172-2023BD 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 as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount Tubes can be used with the BD FACS Loader.; Corrected as of 11/04/2022: Catalog Number: 663028 UDI-DI Code: 00382906630285 Lot Numbers: 2031238 2063994 2095615 2145791 2221697 223704511,709 tubes (corrected 11/04/2022)
Z-0173-2023BD 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 percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.; Corrected as of 11/04/2022: Catalog Number: 662995 UDI-DI Code: 00382906629951 Lot Numbers: 11568 45905 53637 88003 89111 319051,457 tubes (corrected on 11/04/2022)
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product name and lot numbers to confirm if your item is affected.

Where it went and when

Where it was distributed

Distributed in 42 states and D.C., and outside the U.S.

Alaska: not listedAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: not listedWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: not listedWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: not listedNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA 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 WI O.U.S.: Argentina, Australia, Belgium, Bolivia, Brazil,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 37 days after the firm started it.

1. Firm started the recall: Oct 3, 202212. FDA classified it Class II: Nov 3, 202223. Published in FDA’s Enforcement Report: Nov 9, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. 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-0173-2023 (October 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0173-2023 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA