Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0981-2024 — Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410

U.S. FDA — Device Enforcement · United States · 2023-11-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0981-2024
Date of alert
2023-11-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
15099590230623
Reported risk: There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive Insulin APF applies an incorrect conversion factor when converting from system default units of ¿IU/mL to the International System of Units (SI units) of pmol/L.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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