Access 2 Immunoassay Analyzer, Catalog Number 81600N
Reported: March 26, 2025 Initiated: February 5, 2025 #Z-1386-2025
Product Description
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Reason for Recall
Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results.
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 873 units
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
Access 2 Immunoassay Analyzer, Catalog Number 81600N. Recalled by Beckman Coulter, Inc.. Units affected: 873 units.
Why was this product recalled? ▼
Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2025. Severity: Moderate. Recall number: Z-1386-2025.
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