Recall Z-1416-2021 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Becton Dickinson & Co.
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
| Date | Mar 24, 2021 |
| Status | Terminated |
| 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 |
| Root cause | Under Investigation by firm |
| Action | BD issued Urgent Medical Device Correction letter on March 24, 2021 FedEx tracked. Letter states reason for recall, health risk and action to take: 1. Inspect rehydration buffer tubes prior to use for the specific catalog and lot numbers listed below in Attachment A and destroy any products containing partially filled or empty tubes following your institutions process for destruction. 2. Share and Post this medical device recall notification within your facility network to ensure users inspect tubes prior to use. 3. Complete the attached Customer Response Form and return to the BD contact note |
| Quantity | 21,529 Kits |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.