FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: AU Clinical Chemistry Analyzers: Model Number: AU600 Clinical Chemistry Analyzer, AU640 Clinical Chemistry Analyzer, AU640(e) Clinical Chemistry Analyzer, AU680 Clinical Chemistry Analyzer. The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.
- Recall number
- Z-0975-2012
- Recalling firm
- Beckman Coulter Inc.
- Product
- AU Clinical Chemistry Analyzers: Model Number: AU600 Clinical Chemistry Analyzer, AU640 Clinical Chemistry Analyzer, AU640(e) Clinical Chemistry Analyzer, AU680 Clinical Chemistry Analyzer. The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.
- Status
- Terminated
- Initiated
- 2010-07-12
- Posted
- 2012-02-07
- Terminated
- 2014-08-04
- Reason
- The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.
- Root cause
- Under Investigation by firm
- Action
- Beckman Coulter sent an "UPDATE TO PCA -14563: URGENT PRODUCT CORRECTION" letter dated April 27, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter is a communication which describes an alternative approach to detecting cuvette overflow. Additionally, a response form was enclosed for customers to complete and return to the firm. Contact the Customer Support Center at (800) 854-3633 or on the Beckman Coulter website at www.beckmancoulter.com/customersupport/support/default.asp for questions regarding this notification.
- Quantity
- 8225 units
- Distribution
- Worldwide Distribution-including USA (nationwide).
- Lot, serial or model codes
- all analyzer serial numbers
- 510(k) numbers
- ["K961274"]
- 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