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Terminated

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 Recall Z-1704-2017 · Posted 2017-04-03

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2017-02-13
Date Terminated2017-04-12
Product Quantity2 sheets (20 labels/sheet)

Reason for Recall

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

Firm Action

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.

Root Cause

Process control

Distribution Pattern

US Distribution : MA ., Internationally to Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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