Alere Afinion HbA1c and ACR on Afinion 2 analyzer

• • Ongoing Z-1830-2025 FDA Class II ·initiated 24 Apr 2025

  transit 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 failure could increase the probability of an incorrect test result or a delayed test result.

• • Ongoing Z-2736-2024 FDA Class II ·initiated 17 Jun 2024

  Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.

510(k) Number

K171650 ↗

FDA Product Code

LCP

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Cell-Dyn 3000 Multi-Parameter Hematology Analyer

  Class II

  FDA 510(k) K890491 Active Cleared 18 Apr 1989

• Model 340 Spectrophotometer

  Class I

  FDA 510(k) K822720 Active Cleared 8 Oct 1982

• Cell Dyn 800 Hematology Analyzer

  Class II

  FDA 510(k) K803218 Active Cleared 9 Jun 1981

• Cell-Dyn 2000 Automated Multi-Parameter Hematology

  Class II

  FDA 510(k) K852371 Active Cleared 17 Sep 1985

• Cell-Dyn Rapid-Lyse and Hemogloblin

  Class II

  FDA 510(k) K881242 Active Cleared 21 Apr 1988

• Cell-Dyn Brand Hematology Reagents

  Class II

  FDA 510(k) K852372 Active Cleared 3 Sep 1985

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