Z-2754-2020Class II

BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) -

Name: Z-2754-2020 BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) -
Creator: Becton Dickinson & Co.
Published: 2020-07-20
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2020-07-20 / Terminated

FDA source

Becton Dickinson & Co. began a recall of BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative... on 2020-07-20. FDA classified it as Class II and gives the reason as "BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. False positive test results could lead to a delay in diagnosis...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2754-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-20
Posted: 2020-08-04
Terminated: 2021-07-13
Recalling firm: Becton Dickinson & Co
Product: BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: 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: BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. False positive test results could lead to a delay in diagnosis and potentially cause the patient to be exposed to COVID-19 if they are isolated with an infected individual.
FDA root cause: Under Investigation by firm
Action: On July 20, 2020, the firm sent Urgent Medical Device Product Advisory letters to their customers. Customers were informed that all lots are impacted by the elevated rates of potential false positive results. Customers were advised that all positive results are considered presumptive. BD recommends that testing for any positive samples be repeated using an alternate authorized test method. Customers were asked to share the notification with all users of the reagents within their facility to ensure that they are also aware of this product advisory. Customers are to complete and return the customer response form to the recalling firm. US customers who require further assistance may contact BD Customer/Technical Support at 800-638-8663, Monday-Friday, between 7AM-7PM (EST). OUS customers may contact their local BD representative or distributor.
Quantity in commerce: 30,392 to date
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GU, HI, IL, IN, KY, MD, MI, MO, NC, NJ, NY, PA, SC, TN, TX, WI, WY and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Hong Kong, Japan, Mexico, New Zealand, Peru, Philippines, Singapore.
Product codes and lots: All lots are affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2754-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2754-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-12	2020-08-04

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)