ACS Chemiluminescence System Class II 29 units

CIBA Corning ACS 180 Plus Analyzers, used for numerous assays. Recall #Z-359-9.

REASON

A software error for Troponin I analysis caused erroneous results.

CODE

All ACS 180 Plus Analyzers with test definition AL software version.

MANUFACTURER

Chiron Diagnostics Corporation, Oberlin, Ohio.

RECALLED BY

Manufacturer, by letter/technical bulletin on June 9, 1998. Firm-initiated field correction complete.

DISTRIBUTION

Nationwide.

QUANTITY

38 ACS 180 Plus Analyzers were distributed.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
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Dates:  February 4-6, 2020
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QSS Software Validation
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Dates:  June 2-4, 2020
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