Recall Z-1760-2020— Radiometer Medical ApS

Name: FDA recall Z-1760-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-03

Class II · Terminated

Class II FDA medical device recall by Radiometer Medical ApS, initiated 2020-02-03, terminated 2022-09-20. It names one FDA 510(k) clearance: K092686. Product: ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.. Reason: The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment..

Recalling firm: Radiometer Medical ApS
Classification: Class II
Status: Terminated
Initiated: 2020-02-03
Terminated: 2022-09-20
Firm location: Bronshoj, N/A, Denmark

510(k) clearances named in this recall

1 on FDA's record

K092686 — ABL90 FLEX SERIESRadiometer Medical Aps·cleared 2010-08-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

Reason for recall

The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.

Data sourced from openFDA. This site is unofficial and independent of the FDA.