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U.S. Department of Health and Human Services

Class 2 Device Recall BioGX SARSCoV2 Reagents for BD MAX System

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  Class 2 Device Recall BioGX SARSCoV2 Reagents for BD MAX System see related information
Date Initiated by Firm January 07, 2021
Create Date February 05, 2021
Recall Status1 Terminated 3 on December 03, 2021
Recall Number Z-0954-2021
Recall Event ID 87178
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
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.
Code Information Catalog Number: 444213,  Lot Numbers: K20-507, K20-508, K20-509, K20-516, K20-517, K21-020, K21-021.  GTIN Number: 00382904442132
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact Gail Griffiths
410-316-4054
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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