FDA Device recall Z-1416-2021

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in naso…

• FDA Device
• Class II
• terminated
• Published 2021-04-21

On 2021-04-21 the FDA classified a Class II recall of BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in naso… by Becton Dickinson And, citing bioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. A partially filled or….

Read the official FDA Device notice

Product

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

Reason

BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. A partially filled or empty rehydration buffer tube may lead to an Unresolved (UNR) result on the BD MAX" System

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1416-2021%22

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