Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creati

FDA device recall Z-1015-2010 · posted 2010-03-05 · Terminated

Recall details

Recalling firm

Radiometer America Inc

Reason for recall

Analysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. These errors in analytical specifications could lead to inadequate or clinical interventions (therapy) or misleading interpretation of patient status in clinical settings.

Action taken

The recalling firm contacted their customers and notified them of this recall with a letter on 3/26/2009. The letter informs the customer that Radiometer has determined that the Reference Membrane D711 for use in the ABL8x7 Flex Creatinine Analyzer has a shorter in-use lifetime than the previously recommended 1-month interval listed in the Operators Manual. It states that consequently, the firm has changed the recommended replacement intervals as they correspond to the number of samples per day analyzed by the customer and a revised insert is being supplied to the customer which should be placed in the Operators Manual to reflect this new information. The recall notification is also accompanied by an attached response FAX FORM which the customer is asked to complete and to fax back to Radiometer so as to acknowledge receipt of the recall notification letter and the revised insert. Please direct questions to the company TechLine at 1-8007360600 opt 2.

Root cause

Other

Status

Terminated

Product code

CGL

Quantity affected

50 membranes in U. S. distribution

Distribution

The recalled product was distributed customers located in the following states within the U.S.: CT, FL, GA, IL, MA, MD, MN, MO, NC, NM, OH, PA, VA, WA, WI, and WV. Product was also sold in the followi

Date initiated

2009-03-26

Date posted

2010-03-05

Date terminated

2012-05-09

Location

Westlake, OH

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