Recall Z-1233-2025— BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.

Name: FDA recall Z-1233-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-10

Class II · Ongoing

Class II FDA medical device recall by BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD., initiated 2025-01-10. It names one FDA 510(k) clearance: K220977. Product: DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.. Reason: Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade..

Recalling firm: BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
Classification: Class II
Status: Ongoing
Initiated: 2025-01-10
Firm location: Suzhou, N/A, China

510(k) clearances named in this recall

1 on FDA's record

K220977 — ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.·cleared 2023-07-20

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

DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

Reason for recall

Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.

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