—#185489

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.

FDA product code: QJR — Reagents, 2019-Novel Coronavirus Nucleic Acid
Device class: Class N
Medical specialty: Unknown
Affected lot / code info: Catalog Number: 444213, Lot Numbers: K20-507, K20-508, K20-509, K20-516, K20-517, K21-020, K21-021. GTIN Number: 00382904442132

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: US nationwide distribution.

Timeline

Recall initiated: 2021-01-07
Terminated: 2021-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185489. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.