Recall – Analyzer software mismatched patient results

Company: Radiometer America Inc
Date of Enforcement Report: 12/22/2018
Class II

PRODUCT

ABL800 analyzer, model numbers 393-800 and 393-801.

Recall Number: Z-0682-2019

REASON

The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.

RECALLING FIRM/MANUFACTURER

Radiometer America Inc, Brea, CA on 7/3/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2,131 Analyzers

DISTRIBUTION
U.S. Nationwide (including Military/Government) and Canada

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

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