—#153343

Product

Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and ion selective electrode.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K112412, K961274
Affected lot / code info: Not applicable

Why it was recalled

Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.

Root cause (FDA determination)

Process control

Action the firm took

Beckman Coulter sent an Urgent Medical Device Recall letter dated February 13, 2017, was sent to customers to inform them that Beckman Coulter has identified a mismatch in Rack ID Labels (REF MU9074); the Rack ID number displayed and the Rack ID barcode label do not match. Rack ID labels numbered 0161 thru 0180 may be read as 0141 thru 0160 on the AU System. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact their Customer Support Center: http://www.beckmancoulter.com/customersupport/support, call 1-800-854-3633 in the United States and Canada; Outside the United States and Canada, contact their Beckman Coulter representative.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: US Distribution : MA ., Internationally to Japan

Timeline

Recall initiated: 2017-02-13
Posted by FDA: 2017-04-03
Terminated: 2017-04-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153343. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.