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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

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