---
title: "QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 69... — FDA record Z-0455-2022 | Is It on Recall"
description: "The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge"
url: https://isitonrecall.com/recall/fda-device-z-0455-2022-qiastat-dx-respiratory-sars-cov-2-panel-us-ivd-under-fda-eua-200075-ref-691223/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223 — FDA record Z-0455-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 8, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
- **Reason**: The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.
- **Classification**: Class II
- **Recalling firm**: Qiagen Sciences LLC
- **Quantity**: 376 kits
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0455-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0455-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | LOT 210209 UDI (01)14053228038846(17)211127(10)210209(24)691223 Serial Numbers: 412092551 412092559 412092552 412092560 412092553 412092561 412092554 412092563 412092555 412092564 412092556 412092565 412092557 412092566 412092558 412092567 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alabama](https://isitonrecall.com/state/alabama/)
- [District of Columbia](https://isitonrecall.com/state/district-of-columbia/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [Maine](https://isitonrecall.com/state/maine/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Jan 12, 2022
- **Recall initiation date**: Nov 8, 2021
- **Center classification date**: Jan 5, 2022
- **Termination date**: Mar 29, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0455-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Qiagen Sciences LLC records](https://isitonrecall.com/brand/qiagen-sciences-llc/)