NeuMoDx recalls SARS-CoV-2 test strips with lot number 123909 due to potential mismatch between packaging and barcode labels, causing incorrect lot registration in instruments.
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.
NeuMoDx is recalling SARS-CoV-2 test strips with lot number 123909 because the instrument may register the wrong lot number from the barcode label. This mismatch could lead to incorrect test results if the instrument uses the wrong lot number for quality control.
The test strips' packaging and barcode labels may have different lot numbers. When the instrument reads the barcode label, it might register lot number 123910 instead of 123909, potentially causing incorrect test results.
Healthcare providers using NeuMoDx SARS-CoV-2 test strips with lot number 123909 (expiring December 8, 2023) are most at risk of incorrect test results due to the lot number mismatch.
Check for lot number 123909 on the test strip packaging and expiration date of December 8, 2023. The product has a REF number 300800 and GTIN 10814278021264.
Verify the lot number on the test strip packaging is 123909 and expiration date is December 8, 2023.
The instrument may register the wrong lot number (123910) from the barcode label instead of 123909, potentially causing incorrect test results.
Check the lot number on the packaging; if it's 123909 with expiration date December 8, 2023, you should verify the lot number matches the instrument's registration.
The official recall does not provide a fix; users must check the lot number and expiration date.
We’ve drafted a message you can send NeuMoDx to request your refund or repair — edit it as you like.
Subject: Recall Z-2093-2023 — NeuMoDx NeuMoDx Hello, I own a NeuMoDx that is covered by recall Z-2093-2023 from NeuMoDx. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
