Official recall record
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-11-21
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 15099590230623
- Brand on record
- Beckman Coulter, Inc.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 2 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2024-04-18 · US FDA — Medical Devices
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic - 2024-07-10 · US FDA — Medical Devices
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137;
Other recalls from this brand
- 2026-09-21 · US FDA — Medical Devices
ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima X - 2026-09-21 · US FDA — Medical Devices
ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima X - 2026-08-12 · US FDA — Medical Devices
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
All 39 official recall notices naming Beckman Coulter, Inc. on this site →