Z-0954-2021Class II

BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2...

Name: Z-0954-2021 BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2...
Creator: Becton Dickinson & Co.
Published: 2021-01-07
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2021-01-07 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of 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... on 2021-01-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0954-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-07
Posted: 2021-02-05
Terminated: 2021-12-03
Recalling firm: Becton Dickinson & Co
Product: 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.
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On January 12, 2021, BD issued an Urgent Device Correction notice to customers via letters with FedEx tracking. A customer response form is included with the letter that the customer is instructed to complete electronically, email or fax back to BD. Returned response forms will be reconciled with the customer list.
Quantity in commerce: 938 kits
Distribution: US nationwide distribution.
Product codes and lots: Catalog Number: 444213, Lot Numbers: K20-507, K20-508, K20-509, K20-516, K20-517, K21-020, K21-021. GTIN Number: 00382904442132

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0954-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0954-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)