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.
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.
The kit may produce false positive results for Bordetella parapertussis (BPP) up to 16.7% of the time. This means the test might incorrectly indicate infection when there is none, potentially leading to unnecessary treatments or follow-up tests.
Users of the Solana Bordetella kit for Bordetella testing are affected. Healthcare providers and labs using the kit for BPP testing are most at risk.
Check for model number M308 on the kit. Affected lots have expiration dates through 2027, including specific lot codes like 245251 through 268479.
Verify the expiration date on the kit label; affected lots expire through 2027.
Reach out to Ortho-Clinical Diagnostics for specific lot information and guidance.
The recall is due to a potential false positive rate of up to 16.7% for Bordetella parapertussis (BPP) results in affected lots.
Model number M308 with specific lot codes from 245251 through 268479, expiring through 2027.
No, the recall does not require immediate discontinuation; users should check expiration dates and contact the manufacturer for guidance.
We’ve drafted a message you can send Solana to request your refund or repair — edit it as you like.
Subject: Recall Z-1948-2025 — Solana Solana Hello, I own a Solana that is covered by recall Z-1948-2025 from Solana. 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.
