CLASS II ONGOING Device recall · Reported 9 Nov 2022 · FDA Enforcement Report
BD Multitest 6-Color TBNK with optional BD Trucount Tubes recalled
Becton, Dickinson and Company, BD Biosciences is recalling BD Multitest 6-Color TBNK with optional BD Trucount Tubes (, distributed in 43 states. The recall was initiated on 3 Oct 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-0173-2023
- FDA event ID
- 90866
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences, San Jose, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Oct 2022
- FDA classified
- 3 Nov 2022
- Reported
- 9 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Oct 2022 | Recall initiated by company | |
| 3 Nov 2022 | Classified by FDA | +31 days |
| 9 Nov 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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 percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.
Where it was distributed
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
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Is BD Multitest 6-Color TBNK with optional BD Trucount Tubes ( recalled?
Yes. Becton, Dickinson and Company, BD Biosciences recalled BD Multitest 6-Color TBNK with optional BD Trucount Tubes ( on 3 Oct 2022. The recall is Class II and its status is Ongoing. Recall number Z-0173-2023.
Why was it recalled?
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.
Which lots are affected?
Corrected as of 11/04/2022: Catalog Number: 662995 UDI-DI Code: 00382906629951 Lot Numbers: 11568 45905 53637 88003 89111 31905
Where was it sold?
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
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.
More recalls from Becton, Dickinson and Company, BD Biosciences
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BD Multitest 6-Color Tbnk Ce-ivd recalled by Becton, Dickinson and | Becton, Dickinson and Company, BD Biosciences | Lead & Heavy Metals | 34 states |
| Device | CLASS II | CD11b APC: ASR recalled by Becton, Dickinson and | Becton, Dickinson and Company, BD Biosciences | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | BD Trucount Tubes recalled by Becton, Dickinson and | Becton, Dickinson and Company, BD Biosciences | Other | 43 states |
| Device | CLASS II | BD Trucount Tubes recalled by Becton, Dickinson and | Becton, Dickinson and Company, BD Biosciences | Other | 43 states |
| Device | CLASS II | BD Anti-Kappa APC recalled by Becton, Dickinson and | Becton, Dickinson and Company, BD Biosciences | Other | Nationwide |
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