---
title: "QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not s... — FDA record Z-2246-2023 | Is It on Recall"
description: "Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated"
url: https://isitonrecall.com/recall/fda-device-z-2246-2023-qiastat-dx-respiratory-sars-cov-2-panel-v1-and-v2-ce-ivd-not-us-ivd-not-sold-in-the-us-qualitative-t/
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 (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intende... — FDA record Z-2246-2023

Reported ongoing

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 May 19, 2023. 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 (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214
- **Reason**: Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
- **Classification**: Class II
- **Recalling firm**: Qiagen GmbH
- **Quantity**: 4155 kits
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2246-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2246-2023%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 Numbers: LOTs 172043034, 172043348, 172043349, 172043369, 172044712, 172048091, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669, 172046775, 172048381 Exp. Date: 2023-10-06 and 2023-10-17 |

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

## Distribution

DC, AL, CA, FL, GA, ME, NC, NY, OR, TX Foreign: DE, AE, AT, BE, BG, CH, CL, CY, CZ, DE, DK, ES, FI, FR, GB, GR, GT, HK, HU, ID, IN, IT, JO, MC, MU, MY, NL, NA, PL, PT, RO, SE, SK, TH, TN, TW, UY, YT, ZA

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/)
- [California](https://isitonrecall.com/state/california/)
- [District of Columbia](https://isitonrecall.com/state/district-of-columbia/)
- [Delaware](https://isitonrecall.com/state/delaware/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Idaho](https://isitonrecall.com/state/idaho/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Maine](https://isitonrecall.com/state/maine/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Aug 2, 2023
- **Recall initiation date**: May 19, 2023
- **Center classification date**: Jul 27, 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-2246-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Qiagen GmbH records](https://isitonrecall.com/brand/qiagen-gmbh/)