QIAstat-Dx Respiratory SARS-CoV-2 Test Kit Recalled for False Result Risk
Qiagen Sciences LLC recalls 347 QIAstat-Dx Respiratory SARS-CoV-2 test kits due to faulty cartridges that could produce false results. Affected kits were distributed nationwide in nine states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with risk-of-harm (false SARS-CoV-2 test results) where no illnesses or injuries have been reported. The source explicitly states only the theoretical potential for false results, not actual incidents.
Plain-English summary
Qiagen Sciences LLC is recalling 347 QIAstat-Dx Respiratory SARS-CoV-2 Panel test kits because cartridges in the affected lot could produce false test results.
The recall affects Lot 175011350 with specific serial numbers distributed nationwide to healthcare facilities in California, Florida, Illinois, Maryland, Mississippi, New York, Oklahoma, Pennsylvania, and Tennessee.
Healthcare providers and laboratories that received these kits should stop using them and verify their serial numbers against the recall information. Any kits matching the affected lot and serial numbers should be removed from service and the manufacturer contacted. False test results could lead to misdiagnosis and improper patient care decisions.
The recalled product
- Product
- QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
- Manufacturer
- Qiagen Sciences LLC
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 347
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 (10)
- GTIN 14053228038846
- Lot 175011350
- Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655
- 330569651
- 330569650
- 330569646
- 330569645
- 330569644
- 330569643
- 330569641.
Distribution
Related recalls
Same manufacturer · Qiagen Sciences LLC
See all →- HighRespiratory Diagnostic Cartridges Recalled for Risk of False Test Results
FDA (Devices) · 2025-04-09
- HighQiagen QIAcube Connect MDx heating failure may cause erroneous diagnostic results
FDA (Devices) · 2024-07-24
- HighNucleic Acid Isolation Device Recall: EZ2 Connect MDx-IVD Heater Failure
FDA (Devices) · 2024-04-17
- HighLaboratory device displays incorrect sample volume guidance during setup
FDA (Devices) · 2022-09-21
- HighRT-PCR Kit Recalled Due to False Positive Test Results
FDA (Devices) · 2022-09-07
Same hazard · false test results
See all →- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- SevereBeckman Coulter MicroScan Panel Update DVD Kits Recalled
FDA (Devices) · 2026-08-12
- HighMedical Device Recall: PTH Assay on DxI 9000 Analyzer May Produce Inaccurate Results
FDA (Devices) · 2024-12-18
- HighSiemens Atellica CH diagnostic reagent carryover may cause false laboratory test results
FDA (Devices) · 2023-09-06
- HighAlinity c Hemoglobin Reagent Kit Recall Due to Potentially Falsely Elevated Results
FDA (Devices) · 2022-08-03
Similar recalls
- HighCOVID-19 Diagnostic Kit Recall for Inaccurate Test Results
FDA (Devices) · 2022-01-12
- ModerateCOVID-19 Diagnostic Test Kits Recalled Due to Performance Reliability Issues
FDA (Devices) · 2023-08-02
- HighRespiratory Diagnostic Test Kits Recalled for Decreased Performance Reliability
FDA (Devices) · 2023-08-02
- HighRespiratory Diagnostic Cartridges Recalled for Risk of False Test Results
FDA (Devices) · 2025-04-09
- HighQiagen SARS-CoV-2 Test Panel Recalled for Influenza A False Positives
FDA (Devices) · 2020-09-16
- HighQiagen SARS-CoV-2 Antigen Test Recalled for Potential False Positive Results
FDA (Devices) · 2021-02-10