Sendx Medical Inc: Medical Device Recall in 2012 - (Recall #: Z-2304-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting.

Product Classification:

Class II

Date Initiated: June 6, 2012

Date Posted: September 5, 2012

Recall Number: Z-2304-2012

Event ID: 60514

Reason for Recall:

The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.

Status: Terminated

Product Quantity: ABL80 FLEX is 1680, ABL80 CO-OX is 1759

Code Information:

Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers

Distribution Pattern:

Worldwide Distribution - US Nationwide including the state of OH.

Voluntary or Mandated:

Voluntary: Firm initiated