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Z-2754-2020 Class II Terminated

Recalled by Becton Dickinson & Co. — Sparks, MD

FDA device recall Z-2754-2020 was initiated by Becton Dickinson & Co. on July 20, 2020 and is designated Class II. 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 de… The recall status is terminated (terminated July 13, 2021). Affected quantity: 30,392 to date.

Recall Details

Product Type
Devices
Report Date
August 12, 2020
Initiation Date
July 20, 2020
Termination Date
July 13, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30,392 to date

Product Description

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.

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.

Distribution Pattern

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.

Code Information

All lots are affected

Other recalls by Becton Dickinson & Co.

  • Z-2250-2026 Class I — BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, (April 27, 2026)
  • Z-2252-2026 Class I — BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, (April 27, 2026)
  • Z-2249-2026 Class I — BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, (April 27, 2026)
  • Z-2251-2026 Class I — BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, (April 27, 2026)
  • Z-2253-2026 Class I — BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x (April 27, 2026)
  • Z-2254-2026 Class I — BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, (April 27, 2026)
  • Z-2257-2026 Class I — BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, (April 27, 2026)
  • Z-2248-2026 Class I — BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, (April 27, 2026)
  • Z-2255-2026 Class I — BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, (April 27, 2026)
  • Z-2256-2026 Class I — BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, (April 27, 2026)

FDA data resources