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NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasa...

FDA Recall #Z-2093-2023 — Class III — May 15, 2023

Recall #Z-2093-2023 Date: May 15, 2023 Classification: Class III Status: Ongoing

Product Description

NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800

Reason for Recall

Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The instrument registers the non-human readable text as lot number 123910 from the barcode label.

Recalling Firm

NeuMoDx Molecular Inc — Ann Arbor, MI

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Devices

Product Quantity

1,086 test strips

Distribution

US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.

Code Information

GTIN: 10814278021264 Lot Number: 123909 Exp. Date: 08-Dec-2023

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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