Lower riskMedical device recall · FDA · Published May 15, 2023
NeuMoDx SARS-CoV-2 Test Strips: Lot Number Mismatch Risk
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.
Take action
Contact the company
📍Recalling firmNeuMoDx Molecular Inc1250 Eisenhower Pl · Ann Arbor, MI 48108-3281
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/58300-neumodx-sars-cov-2-test-strips-lot-number-mismatch-risk.
“NeuMoDx SARS-CoV-2 Test Strips: Lot Number Mismatch Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58300-neumodx-sars-cov-2-test-strips-lot-number-mismatch-risk. Based on FDA recall #Z-2093-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2093-2023%22&limit=1).
The FDA announced on May 15, 2023, that NeuMoDx Molecular Inc is recalling NeuMoDx SARS-CoV-2 Assay test strips due to potential lot number discrepancies. The hazard involves the instrument registering an incorrect lot number from the barcode label.
How to tell if you have it
Brand: NeuMoDx
Product: NeuMoDx SARS-CoV-2 Assay -IVD
UPC: 10814278021264
Lot Number: 123909
Expiration Date: 08-Dec-2023
REF Number: 300800
The hazard
The recall addresses potential for lot number discrepancies between the test strip packaging and the barcode label. The instrument registers the non-human readable text as lot number 123910 from the barcode label.
Context
GovInfoNow's records show NeuMoDx Molecular Inc has 5 other recalls on record since May 4, 2021. On May 24, 2023, the company recalled cartridges because incorrect labels may cause false positives in PCR tests. A May 13, 2022 recall cited potential for reduced analytical sensitivity in NeuMoDx Flu A-B/RSV/SARS-CoV-2 Test Strips that may lead to false negatives. Another February 18, 2022 recall involved cartridges that may give false SARS-CoV-2 results.
How to tell if you have this one
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.
Brand
NeuMoDx
Product
NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Verify the lot number on the test strip packaging is 123909 and expiration date is December 8, 2023.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Michigan, New Mexico, New York, Tennessee, Texas.
Recall timeline
FDA published this recall 58 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2093-2023 (May 15, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2093-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.