Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 17, 2021
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test 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.
Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N…
Becton Dickinson & Co. recalled BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagn… - a moderate-severity action.
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagn… was recalled by Becton Dickinson & Co. in February 17, 2021. Reason: Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may…. Check the official notice for the remedy. Verify recall #Z-0954-2021 with the FDA Devices before acting.
The recall
Becton Dickinson & Co. issued this moderate-severity FDA Devices recall-Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may….
- Moderate
- severity level
- Class II
- classification
- February 17, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0954-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0954-2021) was formally reported on February 17, 2021, with the manufacturer initiating the action on January 7, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Becton Dickinson & Co. is listed as the recalling firm, operating out of Sparks, MD. Federal records list the affected scope as 938 kits.
The documented reason for this recall is: Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master… Distribution data in the federal record shows the product reached: US nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
938 kits
Related Recalls
6
3 from same agency
Product description
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test 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.
Reason for recall
Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master mix, instead of one pouch of each. If laboratory personnel do not notice that both pouches contain tubes with the same color foil seal and use two of the same tubes, there is a low potential for a false negative SARS-CoV-2 result. A false negative SARS-CoV-2 result could lead to an increased risk of disease progression for the patient and additional spread of SARS-CoV-2 if the patient is not quarantined.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0954-2021 |
| Date reported | February 17, 2021 |
| Date initiated | January 7, 2021 |
| Recalling firm | Becton Dickinson & Co. |
| Firm location | Sparks, MD |
| Affected scope | 938 kits |
| Distribution | US nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0954-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test 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.. Recalled by Becton Dickinson & Co.. Units affected: 938 kits.
Why was this product recalled? ▼
Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master mix, instead of one pouch of each. If laboratory personnel do not notice that both pouches contain tubes with the same color foil seal and use two of the same tubes, there is a low potential for a false negative SARS-CoV-2 result. A false negative SARS-CoV-2 result could lead to an increased risk of disease progression for the patient and additional spread of SARS-CoV-2 if the patient is not quarantined.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 17, 2021. Severity: Moderate. Recall number: Z-0954-2021.
Where was the recalled product distributed? ▼
Distribution: US nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0954-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 17, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.