QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Nu...

FDA Device Recall #Z-1683-2023 — Class II — April 28, 2023

Recall Summary

Recall Number Z-1683-2023
Classification Class II — Moderate risk
Date Initiated April 28, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Qiagen Sciences LLC
Location Germantown, MD
Product Type Devices
Quantity 347 kits

Product Description

QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

Reason for Recall

Faulty cartridges in the lot could result in false test results.

Distribution Pattern

US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.

Lot / Code Information

GTIN 14053228038846; Lot 175011350; Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655, 330569651, 330569650, 330569646, 330569645, 330569644, 330569643, 330569641.

Other Recalls from Qiagen Sciences LLC

Recall # Classification Product Date
Z-1504-2025 Class II Brand Name: QIAstat-Dx Product Name: QIAstat-D... Mar 12, 2025
Z-2353-2024 Class II QIAcube Connect MDx - IVD Instrument designed t... Jun 3, 2024
Z-1508-2024 Class II EZ2 Connect MDx-IVD Designed to perform automat... Mar 4, 2024
Z-1652-2022 Class II FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010 Jul 20, 2022
Z-1651-2022 Class II therascreen FGFR RGQ RT-PCR Kit (CE IVD, not so... Jul 20, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.