Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
Reported: December 17, 2025 Initiated: November 7, 2025 #Z-0889-2026
Product Description
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
Reason for Recall
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 38,225 untis
- Distribution
- US Nationwide. Global Distribution.
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901. Recalled by Beckman Coulter, Inc.. Units affected: 38,225 untis.
Why was this product recalled? ▼
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 17, 2025. Severity: Moderate. Recall number: Z-0889-2026.
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