FDA Device recall Z-2487-2021
SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance…
- FDA Device
- Class II
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance… by Microbiologics, citing the product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2487-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-20 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | US |
Product
SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
Reason
The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.
Identifiers
| code_info | Catalog # HE0063S Lot #'s: HE0063-100-1, HE0063-103-2, HE0063-103-3, HE0063-103-1, HE0063-104-1, HE0063-101-1 and HE0063-100-1. |
|---|
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-2487-2021%22
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