CLASS II ONGOING Device recall · Reported 12 Jun 2024 · FDA Enforcement Report
BD Sars-CoV-2 Reagents for BD MAX" Systems recalled
Becton Dickinson & is recalling BD Sars-CoV-2 Reagents for BD MAX" Systems, distributed nationwide in the US. The recall was initiated on 7 May 2024 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-2023-2024
- FDA event ID
- 94599
- Recalling firm
- Becton Dickinson &, Sparks, MD
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 May 2024
- FDA classified
- 5 Jun 2024
- Reported
- 12 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 7 May 2024 | Recall initiated by company | |
| 5 Jun 2024 | Classified by FDA | +29 days |
| 12 Jun 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.
Where it was distributed
Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.
Questions about this recall
Is BD Sars-CoV-2 Reagents for BD MAX" Systems recalled?
Yes. Becton Dickinson & recalled BD Sars-CoV-2 Reagents for BD MAX" Systems on 7 May 2024. The recall is Class II and its status is Ongoing. Recall number Z-2023-2024.
Why was it recalled?
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
Which lots are affected?
Catalog No. 445003-01; UDI-DI: (01) 60382904450030 (17) 240803 (10) 3291356 (20) 01 (30) 1, (01) 60382904450030 (17) 241119 (10) 3291358 (20) 01 (30) 1, (01) 60382904450030 (17) 241217 (10) 3326001 (20) 01 (30) 1; Lot No. 3291356 (Exp. 8/3/24), 3291358 (Exp. 11/19/24), 3326001 (Exp. 12/17/24).
Where was it sold?
Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.
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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