FDA Device recall Z-1683-2023
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
- FDA Device
- Class II
- ongoing
- Published 2023-06-14
On 2023-06-14 the FDA classified a Class II recall of QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223 by Qiagen Sciences, citing faulty cartridges in the lot could result in false test results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1683-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-28 |
| Published | 2023-06-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Qiagen Sciences |
| Distribution | US |
Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Reason
Faulty cartridges in the lot could result in false test results.
Identifiers
| code_info | GTIN 14053228038846; Lot 175011350; Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655, 3305696…GTIN 14053228038846; Lot 175011350; Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655, 330569651, 330569650, 330569646, 330569645, 330569644, 330569643, 330569641. |
|---|
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-1683-2023%22
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