Sendx Medical Recalls ABL80 FLEX Blood Gas Analyzers for Glucose Errors
Sendx Medical Inc is recalling ABL80 FLEX and ABL80 FLEX CO-OX analyzers because glucose measurements may be inaccurate and not reflect patient clinical conditions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where inaccurate glucose measurements could lead to incorrect clinical decisions, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Sendx Medical Inc is recalling the ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) pH Blood Gas and Electrolytes Analyzer Systems. The recall involves 1,680 units of the ABL80 FLEX and 1,759 units of the ABL80 FLEX CO-OX. These portable, automated analyzers are intended for use by trained technologists, nurses, physicians, and therapists in laboratory, near-patient, or point-of-care settings to measure pH, blood gases, electrolytes, glucose, and oximetry in whole blood.
The firm initiated the recall because glucose measurements from a patient sample were found to be too low and did not reflect the patient's clinical condition. The affected products include Model Numbers 393-839 (with 933-082 software) and 393-841 (with 933-132 software) with all serial numbers. The devices were distributed worldwide, including nationwide in the United States and the state of Ohio.
Healthcare facilities and users should stop using the affected devices and contact Sendx Medical Inc for further instructions on the recall. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
The recalled product
- 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 gase
- Manufacturer
- Sendx Medical Inc
Distribution
Related recalls
Same manufacturer · Sendx Medical Inc
See all →- HighSendx Medical Recalls ABL80 FLEX CO-OX Analyzers Due to Software Error
FDA (Devices) · 2012-11-14
Same hazard · inaccurate measurement
See all →- ModerateFujifilm Synapse PACS Software Recalled for Inaccurate Ruler Measurements
FDA (Devices) · 2026-09-02
- HighMerge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements
FDA (Devices) · 2026-09-02
- High3mensio Workstation Software Recalled Due to Inaccurate Cardiovascular Measurements
FDA (Devices) · 2026-07-29
- HighOral thermometer probes recalled after being programmed with rectal configuration
FDA (Devices) · 2025-10-29
- HighUltrasound systems recalled over inaccurate liver steatosis measurement values
FDA (Devices) · 2025-10-22