COVID-19 Diagnostic Test Kits Recalled Due to Performance Reliability Issues
Qiagen has recalled 4155 QIAstat-Dx Respiratory SARS-CoV-2 Panel kits due to decreased performance reliability. Test failures (run abortions) may require samples to be retested, potentially delaying diagnosis.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a functional performance defect (test failures) rather than a direct physical or chemical threat. While diagnostic delays are problematic, the source documents no actual adverse patient outcomes.
Plain-English summary
Qiagen GmbH is recalling 4155 QIAstat-Dx Respiratory SARS-CoV-2 Panel kits (versions V1 and V2). These are qualitative diagnostic tests designed to detect SARS-CoV-2 in nasopharyngeal swab samples from patients suspected of respiratory infection.
The recall was initiated because the company identified a decreased performance reliability rate in these kits. Run abortions—cases where the test fails during execution—can occur with these lots, requiring that samples be retested. This can cause a delay in diagnosis for patients awaiting test results.
The affected kits were distributed across multiple US states (DC, AL, CA, FL, GA, ME, NC, NY, OR, TX) and to numerous foreign locations. The recalled lot numbers are 172043034, 172043348, 172043349, 172043369, 172044712, 172048091, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669, 172046775, and 172048381, with expiration dates of October 6, 2023 or October 17, 2023.
The recalled product
- 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
- Manufacturer
- Qiagen GmbH
- Affected units
- 4,155
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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
Distribution
Part of a larger recall action
This product is one of 2 recalled by Qiagen GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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