FDA Device recall Z-0162-2022
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
- FDA Device
- Class II
- ongoing
- Published 2021-10-27
On 2021-10-27 the FDA classified a Class II recall of SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051 by Diasorin Molecular, citing due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0162-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-23 |
| Published | 2021-10-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Diasorin Molecular |
| Distribution | US |
Product
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Reason
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
Identifiers
| code_info | Lot #/Expiration Date: 12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, X12724N/08.31.2022 |
|---|
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-0162-2022%22
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