Lower riskMedical device recall · FDA · Published March 24, 2025
Solana Bordetella Kit Recall: False Positive Risk Up to 16.7%
Ortho-Clinical Diagnostics recalls Solana Bordetella kit (model M308) due to potential false positives in Bordetella parapertussis tests. Affected lots have expiration dates through 2027.
It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.
Take action
Contact the company
📍Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101
✎ GovInfoNow plain-language explainer
Ortho-Clinical Diagnostics recalls Solana Bordetella kits with model number M308 because they may give false positive results for Bordetella parapertussis (BPP) tests. This could lead to incorrect diagnoses if used without proper verification. Read more at govinfonow.com/recall/52558-solana-bordetella-kit-recall-false-positive-risk-up-to-16.
“Solana Bordetella Kit Recall: False Positive Risk Up to 16.7%.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52558-solana-bordetella-kit-recall-false-positive-risk-up-to-16. Based on FDA recall #Z-1948-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1948-2025%22&limit=1).
The FDA announced on March 24, 2025, that Ortho-Clinical Diagnostics, Inc. is recalling Solana Bordetella kits due to a potential false positive rate of up to 16.7% for Bordetella parapertussis results. The agency issued recall number Z-1948-2025 for the Class II voluntary recall.
How to tell if you have it
Brand: Solana
Product Name: Solana Bordetella kit
Model/Catalog Number: M308
Lot Codes: 245251, 246941, 250163, 259686, 261072, 262113, 263331, 264065, 265007, 266928, 265007-1, and 268479 and above
Units affected: 952
The hazard
The recall addresses a determined possibility of false positive results for Bordetella parapertussis (BPP) associated with the affected lots. The hazard is limited to BPP results only and does not affect other components of the assay.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since July 10, 2017. Recent brand recalls include calibration failures affecting VITROS Chemistry Products LAC Slides reported on July 29, 2025, and Condition Code TH4-63J issues with VITROS Ca Slides reported on July 9, 2025. Other recent recalls of similar products include Diagnostica Stago Asserachrom HPIA Kit Recall (Dec. 15, 2025), Hologic Aptima HPV Assay Kit Recall (Feb. 18, 2026), and Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026).
How to tell if you have this one
Check for model number M308 on the kit. Affected lots have expiration dates through 2027, including specific lot codes like 245251 through 268479.
Brand
Solana
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Expiration
Verify the expiration date on the kit label; affected lots expire through 2027.
Contact Manufacturer
Reach out to Ortho-Clinical Diagnostics for specific lot information and guidance.
How this recall unfolded
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
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-1948-2025 (March 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1948-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.