BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for… — Class II medical device recall Z-1416-2021
Terminated recall by Becton Dickinson & Co., reported 2021-04-21, distributed nationwide. BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some
| Recall number | Z-1416-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2021-03-24 |
| Classified | 2021-04-12 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2022-08-02 |
| Distributed | Nationwide (US) |
| Quantity | 21,529 kits |
| UPC / GTIN / UDI-DI | 00382904442132 |
| Lot numbers | K20-347, K20-348, K20-352, K20-353, K20-354, K20-355, K20-356, K20-357, K20-358, K20-366, K20-367, K20-373, K20-376, K20-377, K20-378, K20-379, K20-380, K20-381, K20-382, K20-385, K20-386, K20-511, K20-512, K20-513, K20-514, K20-515, K20-516, K20-517, K20-518, K20-519, K20-520, K20-521, K20-522, K20-523, K20-524, K20-525, K20-526, K20-527, K20-528, K20-529 and 114 more |
| Model numbers | 444213 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1416-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.