Platelet reactivity tests recalled after an uncleared device was distributed
Accriva Diagnostics is recalling 125 boxes, 3,125 tests, of VerifyNow PRUTest because a device without premarket clearance was incorrectly packaged and distributed.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the FDA designated this Class III and the record cites a packaging and premarket clearance error rather than a performance defect.
Plain-English summary
The VerifyNow PRUTest Platelet Reactivity Test, REF 85225, is being recalled. The test is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.
The recall follows a device without premarket clearance being incorrectly packaged and distributed.
The recall covers 125 boxes, totalling 3,125 tests, from lot WP1559-01, carrying UDI-DI 10711234150078. The product was distributed in Alaska, California, Florida, Iowa, Illinois, Maryland, Michigan, New York, South Dakota and Texas, and internationally. The FDA has classified the recall as Class III, its least serious category.
The enforcement record describes a packaging and clearance error rather than an identified performance defect, and reports no injuries. Laboratories holding lot WP1559-01 should follow the firm's instructions.
The recalled product
- Product
- VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.
- Manufacturer
- Accriva Diagnostics, Inc.
- Category
- Medical Device — Diagnostic test
- Hazard
- missing-clearance
- packaging-error
- class-iii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01
Distribution
Distributed nationwide across the United States.
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