Radiometer America Inc: Medical Device Recall in 2019 - (Recall #: Z-0682-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 3, 2018

Date Posted: January 2, 2019

Recall Number: Z-0682-2019

Event ID: 81547

Reason for Recall:

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

Status: Terminated

Product Quantity: 2,131 analyzers

Code Information:

Model 393-800 ABL800 Series w/o Creatinin (All serial numbers) for the following configurations: ABL800, ABL805, ABL810, ABL815, ABL820, ABL825, ABL830, and ABL835. Model 393-801 ABL800 Series with Creatinin (All serial numbers) for the following configurations: ABL817, ABL827, and ABL837.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated