AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer… — Class II medical device recall Z-1430-2013

Terminated recall by Beckman Coulter Inc., reported 2013-06-05, distributed nationwide. Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determine

Recall number	`Z-1430-2013`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Beckman Coulter Inc., Brea, CA, United States
Recall initiated	2013-04-26
Classified	2013-05-29
Reported by FDA	2013-06-05
Terminated	2014-08-04
Distributed	Nationwide (US)
Quantity	108 units
Reason classes	packaging
Model numbers	`1465600`, `64270G`, `64542`, `A94504`, `AU2700`, `AU27000ISE`, `AU5421`, `AU5421ISE`, `AU5431`, `AU5431-U1`, `E0750053`, `E61DAU2700`, `N1683100`, `N3663400`, `N3663500`, `N3663600`, `N3663700`, `N3663800`, `N3663900`, `N3664000`, `N3664100`, `N3664200`, `N3664300`, `N3664400`, `N3664500` and 19 more

Product

AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.

Reason for recall

Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1430-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.