Recall Z-1416-2021— Becton Dickinson & Co.
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Co., initiated 2021-03-24, terminated 2022-08-02. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-24
- Terminated
- 2022-08-02
- Firm location
- Sparks, MD, United States
Product description
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 for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.