Recall record at a glance
| Official record | Z-1416-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Becton Dickinson & Co. |
| Report date | Apr 21, 2021 |
| Recall initiation date | Mar 24, 2021 |
| Quantity | 21,529 Kits |
| Location | Sparks, MD, United States |
Official 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
Why the product was recalled
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
Distribution information
US Nationwide
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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