ABL80 FLEX — Class II medical device recall Z-2304-2012
Terminated recall by Sendx Medical Inc, reported 2012-09-05, distributed nationwide. The firm recalled because the glucose measurements from a patient sample that the customer felt was too low an
| Recall number | Z-2304-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sendx Medical Inc, Carlsbad, CA, United States |
| Recall initiated | 2012-06-06 |
| Classified | 2012-08-30 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2012-09-04 |
| Distributed | Nationwide (US) |
| Serial numbers | ABL80 |
| Model numbers | 393-839 |
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.