Recall Z-2304-2012— Sendx Medical Inc

Name: FDA recall Z-2304-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-06

Class II · Terminated

Class II FDA medical device recall by Sendx Medical Inc, initiated 2012-06-06, terminated 2012-09-04. It names 2 FDA 510(k) clearances: K080370, K051804. Product: 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.. Reason: 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..

Recalling firm: Sendx Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2012-06-06
Terminated: 2012-09-04
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K080370 — ABL 80 CO-OX SYSTEMSendx Medical, Inc.·cleared 2008-07-31
K051804 — ABL80 FLEX ANALYZERSendx Medical, Inc.·cleared 2005-11-01

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

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.

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.

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