Qiagen GmbH: QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Cor

Hazard

If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported

Details from the source

Reason for recall: If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported Distribution: AL, AR, CA, DC, FL, GA, ID, KS, KY, MD, MN, NJ, NY,PA, SC, TX, VA Quantity: 368 kits Lot/code info: GTIN: 14053228038846 LOT Number: 175010712 Affected Serial numbers (SNs) are from 330559516 to 330559783

UPC codes

14053228038846

Source

Official record: FDA (Device enforcement) ↗

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