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FDA (Device enforcement)Recalled 2023-04-28class ii

Qiagen Sciences LLC: QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

Hazard

Faulty cartridges in the lot could result in false test results.

Details from the source

Reason for recall: Faulty cartridges in the lot could result in false test results. Distribution: US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN. Quantity: 347 kits Lot/code info: GTIN 14053228038846; Lot 175011350; Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655, 330569651, 330569650, 330569646, 330569645, 330569644, 330569643, 330569641.

UPC codes

14053228038846

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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