ABL80 FLEX Analyzer, Model #393-839

FDA device recall Z-1196-2007 · posted 2007-08-25 · Terminated

Recall details

Recalling firm

Sendx Medical Inc

Reason for recall

There have been reported experiences where waste fluids have sprayed out from the waste drain at the front of the ABL80 analyzer when excessive pressure builds within the waste line.

Action taken

The recall was initiated 3/27/2007. All distributors were notified via the Radiometer FAN (field action notice) system which provides a communication mechanism for these types of actions. The notice advises that there have been a few reported experiences where waste fluids have sprayed out from the waste drain at the front of the ABL80 analyzer which occurs when excessive pressure builds within the waste line. To prevent any spraying of fluids from the waste drain a check valve has been added to the waste tubing, between the waste drain and the waste pump which allows fluids to flow in one direction thus making it impossible to spray fluids out the waste drain. The letter further advises that all analyzers shipped from SenDx on or after March 16, 2007 will include this check valve. All analyzers already in the field must be updated to include this check valve. Distributors are to distribute a copy of the Customer Advisory Letter associated with this case to all their customers and update all ABL80 analyzers to include the waste drain check valve as per the instructions that accompany the check valve. The Advisory Letter informs the customer of the problem and the new waste drain check valve and provides precautionary instructions such as appropriate hand, eye, face and clothing shields. In addition, it advises that the analyzer should never be used if there is any indication of a waste drain occlusion or blockage. The most typical indication of an occlusion or blockage is fluid overflowing out of the waste drain.

Root cause

Other

Status

Terminated

Product code

CHL

Quantity affected

334 units worldwide

Distribution

Class II Recall - Worldwide Distribution --- USA including state of Ohio, and countries of Austria, Belgium, Denmark, Finland, France, Germany, Italy, Japan, The Netherlands, Norway, Poland, Spain, Sw

Date initiated

2007-03-27

Date posted

2007-08-25

Date terminated

2011-10-13

Location

Carlsbad, CA