Accriva Diagnostics recalls VerifyNow PRUTest Platelet Reactivity Test REF 85225 with UDI-DI code 10711234150078 due to being distributed without premarket clearance. This may pose risks in laboratory or point-of-care testing.
Due to an device without a premarket clearance being incorrectly package and distributed.
Accriva Diagnostics is recalling a specific platelet reactivity test kit because it was distributed without proper regulatory approval. This could lead to inaccurate test results if used in medical settings.
The test kit was distributed without premarket clearance, meaning it wasn't approved by the relevant regulatory body before being sold. This could result in inaccurate test results if used in medical settings, potentially affecting patient care decisions.
Healthcare providers and laboratories that use this specific platelet reactivity test kit are likely affected. Patients using point-of-care testing with this kit may be at risk of inaccurate results.
Check for the product name 'VerifyNow PRUTest Platelet Reactivity Test' with catalog number 85225 and UDI-DI code 10711234150078. This kit was distributed in laboratory or point-of-care settings.
Verify the catalog number (85225) and UDI-DI code (10711234150078) on the test kit.
The test kit was distributed without premarket clearance, meaning it wasn't approved by the relevant regulatory body before being sold.
The recall record does not specify a remedy, so check with Accriva Diagnostics for further instructions.
The recall record states the test kit was distributed without premarket clearance, which could lead to inaccurate results if used in medical settings.
We’ve drafted a message you can send Accriva Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0500-2026 — Accriva Diagnostics Accriva Diagnostics Hello, I own a Accriva Diagnostics that is covered by recall Z-0500-2026 from Accriva Diagnostics. 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.
