COVID-19 Diagnostic Kit Recall for Inaccurate Test Results
Qiagen Sciences is recalling 376 units of its QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kit due to faulty cartridges that can produce false-negative or false-positive test results.
What this means for you
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 a functional defect (incorrect primer-probe mixes) that results in diagnostic test failures. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, resulting in a High (3) score.
Plain-English summary
Qiagen Sciences LLC is recalling 376 units of the QIAstat-Dx Respiratory SARS-CoV-2 Panel, an FDA-authorized diagnostic test kit used to detect SARS-CoV-2 (COVID-19). The affected units are from LOT 210209 and were distributed to locations in Alabama, Washington DC, Kentucky, Maryland, Maine, New Jersey, Oklahoma, Pennsylvania, and Texas.
The recall was initiated because 16 cartridges in LOT 210209 contain incorrect primer-probe mixes in their reaction chambers. If an affected cartridge is used, the test can produce false-negative results (incorrectly showing a patient is negative when they are actually positive), false-positive results (incorrectly showing a patient is positive when they are actually negative), or both types of errors.
Users should check whether they have received units from this lot and contact Qiagen Sciences LLC regarding the specific serial numbers and any necessary corrective actions.
The recalled product
- Product
- QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
- Manufacturer
- Qiagen Sciences LLC
- Hazard
- false-negative
- false-positive
- diagnostic-error
Distribution
Distributed in 9 states:
- AL
- DC
- KY
- MD
- ME
- NJ
- OK
- PA
- TX
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