ACS Chemiluminescence System Class II 1015 units

CIBA Corning Acs:180 and ACS:180 Plus Analyzers, used to conduct various laboratory diagnostictests. Recall #Z-368-9.

REASON

Due to a software error, the ACS Folate and ACS T-Uptake assays may run without the required conditioning solution. As a result, the test results may be outside of the system requirements.

CODE

All serial numbers for the ACS 180 and ACS 180 Plus Analyzers.

MANUFACTURER

Chiron Diagnostics Corp., Oberlin, Ohio.

RECALLED BY

Manufacturer, by letter dated June 14, 1996. Firm-initiated recall complete.

DISTRIBUTION

Nationwide and international.

QUANTITY

1,015 units were distributed.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020

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