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

Upcoming Training

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

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QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.