FDA Device recall Z-1210-2023
Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655
- FDA Device
- Class II
- ongoing
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655 by Diasorin Molecular, citing direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1210-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-01-30 |
| Published | 2023-03-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Diasorin Molecular |
| Distribution | US |
Product
Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
Reason
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
Identifiers
| code_info | UDI-DI: 20816101026962. Product REF/Lot/Reaction Mix REF/Lot: MOL2655/13648N/MOL2656/13649N, MOL2655/13882N/MOL2656/15164N, MOL2655/15279N/MOL2656/15280N |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1210-2023%22
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