CLASS II Device recall · Reported 28 Aug 2019 · FDA Enforcement Report
Kit BD Max ExK DNA 2 EU LUO recalled by Becton Dickinson &
Becton Dickinson & is recalling Kit BD Max ExK DNA 2 EU LUO, distributed in 38 states. The recall was initiated on 17 Jul 2019 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-2326-2019
- FDA event ID
- 83406
- Recalling firm
- Becton Dickinson &, Sparks, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2019
- FDA classified
- 22 Aug 2019
- Reported
- 28 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 17 Jul 2019 | Recall initiated by company | |
| 22 Aug 2019 | Classified by FDA | +36 days |
| 28 Aug 2019 | 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
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
Where it was distributed
AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan
AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMontana
Questions about this recall
Why was it recalled?
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Which lots are affected?
Lot # 9114655; UDI (GTIN, DI+PI): (01)00382904428204 (17)201107(10)9114655(30)1; Exp:11/7/2020
Where was it sold?
AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, 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.
Other products in this recall event
18 other products · FDA event 83406This product is part of a recall event; the main page for the event is Kit BD Max Enteric Viral Panel RUO recalled by Becton Dickinson &.
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