DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
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.
Details
- Recalling Firm
- BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
- Units Affected
- 56
- Distribution
- US: MA, CA, SC, LA, OK, GA, AL, TX, OR, ID, CO, MN, NY, MS, PA, WA, IL, MI, PR. OUS: Lebanon, Poland, Ghana, Spain, South Africa, Slovakia, Ghana, Croatia, Seychelles, Australia, Republic of Korea
- Location
- Suzhou, N/A
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