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ACE

ALFA WASSERMANN, INC. · Model SA2024 · UDI-DI 00857969006266

CDN
10
510(k) clearances
2
Adverse events
2
Recalls
8
Facilities

Description

BUN / UREA Reagent

Recalls

DateFirmReason
2025-04-24Mckesson Medical-Surgical Inc. Corporate Officetransit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur
2013-06-12Ortho-Clinical DiagnosticsOrtho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.