CLASS II Device recall · Reported 12 Aug 2020 · FDA Enforcement Report
BD MAX Sars-CoV-2 Reagents recalled by Becton Dickinson &
Becton Dickinson & is recalling BD MAX Sars-CoV-2 Reagents, distributed nationwide in the US. The recall was initiated on 20 Jul 2020 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-2754-2020
- FDA event ID
- 86061
- Recalling firm
- Becton Dickinson &, Sparks, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jul 2020
- FDA classified
- 4 Aug 2020
- Reported
- 12 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Jul 2020 | Recall initiated by company | |
| 4 Aug 2020 | Classified by FDA | +15 days |
| 12 Aug 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. False positive test results could lead to a delay in diagnosis and potentially cause the patient to be exposed to COVID-19 if they are isolated with an infected individual.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GU, HI, IL, IN, KY, MD, MI, MO, NC, NJ, NY, PA, SC, TN, TX, WI, WY and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Hong Kong, Japan, Mexico, New Zealand, Peru, Philippines, Singapore.
Nationwide ArizonaCaliforniaColoradoDistrict of ColumbiaFloridaHawaiiIllinoisIndianaKentuckyMarylandMichiganMissouriNorth CarolinaNew JerseyNew YorkPennsylvaniaSouth CarolinaTennesseeTexasWisconsin
Questions about this recall
Is BD MAX Sars-CoV-2 Reagents recalled?
Yes. Becton Dickinson & recalled BD MAX Sars-CoV-2 Reagents on 20 Jul 2020. The recall is Class II and its status is Terminated. Recall number Z-2754-2020.
Why was it recalled?
BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. False positive test results could lead to a delay in diagnosis and potentially cause the patient to be exposed to COVID-19 if they are isolated with an infected individual.
Which lots are affected?
All lots are affected
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GU, HI, IL, IN, KY, MD, MI, MO, NC, NJ, NY, PA, SC, TN, TX, WI, WY and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Hong Kong, Japan, Mexico, New Zealand, Peru, Philippines, Singapore.
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.
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