FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
- Recall number
- Z-0984-2014
- Recalling firm
- Beckman Coulter Inc.
- Product
- Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
- Status
- Terminated
- Initiated
- 2013-11-26
- Posted
- 2014-02-16
- Terminated
- 2014-07-27
- Reason
- The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.
- Root cause
- Nonconforming Material/Component
- Action
- Beckman Coulter initiated this recall by sending recall notifications to customers. An Urgent Product Correction letter sent to affected customers. The recall letter dated November 22, 2013 informed customer of the recall, products with description and codes, issue, impact, action, resolution, and contact information.
- Quantity
- 3 units
- Distribution
- Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.
- Lot, serial or model codes
- Part Number 81600N. Serial Numbers 508957, 508963, 508964.
- 510(k) numbers
- ["K922823"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28