ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM— 510(k) K121214

Clearance details

Applicant

Beckman Coulter, Inc.

Product code

Code MMI

Device class

Class 2

Regulation

21 CFR 862.1215

Advisory panel

Clinical Chemistry

Date received

2012-04-23

Decision date

2013-06-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chaska, MN, US

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Injury

172

Malfunction

3,762

Total

3,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0889-2026 — Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901Class II·Ongoing·Beckman Coulter, Inc.·20251107
• Z-1386-2025 — Access 2 Immunoassay Analyzer, Catalog Number 81600NClass II·Ongoing·Beckman Coulter, Inc.·20250205
• Z-0727-2025 — Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.Class II·Ongoing·Beckman Coulter, Inc.·20241118
• Z-1257-2023 — Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).Class II·Ongoing·Beckman Coulter, Inc.·20230126
• Z-0175-2015 — Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.Class II·Terminated·Beckman Coulter Inc.·20141006

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121214.