Recall Z-0981-2024— Beckman Coulter, Inc.

Name: FDA recall Z-0981-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-21

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2023-11-21. It names one FDA 510(k) clearance: K953084. Product: Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410. Reason: 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..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-11-21
Firm location: Chaska, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K953084 — ACCESS ULTRASENSITIVE INSULIN ASSAYBio-Rad Laboratories, Inc.·cleared 1995-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.