Recall Z-2215-2023— Qiagen GmbH

Class II FDA medical device recall by Qiagen GmbH, initiated 2023-05-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 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, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223. Reason: 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.

Recalling firm

Qiagen GmbH

Classification

Class II

Status

Ongoing

Initiated

2023-05-09

Firm location

Hilden, N/A, Germany

Data sourced from openFDA. This site is unofficial and independent of the FDA.