RecallRadar

FDA Device recall Z-1873-2013

Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers

On 2013-08-14 the FDA classified a Class II recall of Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers by Beckman Coulter, citing beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1873-2013
ClassificationClass II
Statusterminated
Initiated2012-10-26
Published2013-08-14
Last updated2026-09-13 11:53 UTC
CompanyBeckman Coulter
DistributionUS

Product

Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.

Reason

Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve.

Identifiers

code_info
Models, Catalogue Numbers: AU5811-01, A94906; AU5811-02, A94907; AU5811-03, A94908; AU5811-04, A94909; AU5811-06,…Models, Catalogue Numbers: AU5811-01, A94906; AU5811-02, A94907; AU5811-03, A94908; AU5811-04, A94909; AU5811-06, A94910; AU5821-01, A94911; AU5821-02, A94912; AU5821-03, A94913; AU5821-04, A94914; AU5821-06, A94915; AU5831-01, A94916; AU5831-02, A94917; AU5831-03, A94918; AU5831-04 A94919; AU5831-06 A94920; AU5831-01 A94921; AU5831-02 A94922; AU5831-03 A94923; AU5831-04 A94924; AU5831-06 A94925.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1873-2013%22

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