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Terminated

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

FDA Recall Z-0682-2019 · Posted None

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2018-07-03
Date Terminated2023-08-30
Product Quantity2,131 analyzers

Reason for Recall

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

Firm Action

The recalling firm issued letters dated 7/3/2018 on 7/3/2018 via FedEx.

Root Cause

Software design

Distribution Pattern

Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041874ABL800 FLEXRadiometer Medical Aps · 2004-10-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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