ABL80 FLEX CO-OX analyzer — Class II medical device recall Z-0195-2013
Terminated recall by Sendx Medical Inc, reported 2012-11-14, distributed in OH. The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX a
| Recall number | Z-0195-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sendx Medical Inc, Carlsbad, CA, United States |
| Recall initiated | 2010-01-06 |
| Classified | 2012-11-05 |
| Reported by FDA | 2012-11-14 |
| Terminated | 2012-11-05 |
| Distributed | OH |
| Countries outside the US | AT, AU, CH, CN, CZ, DE, DK, ES, FR, GB, IT, JP, NL, NO, PL, SE |
| Quantity | 767 units |
| Reason classes | software |
| Serial numbers | ABL80 |
| Model numbers | 393-841 |
Product
ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting
Reason for recall
The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0195-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.