Sendx Medical Recalls ABL80 FLEX CO-OX Analyzers Due to Software Error
Sendx Medical Inc. is recalling 767 ABL80 FLEX CO-OX analyzers because a software issue may cause incorrect reporting of hemoglobin fractional parameters.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with a software defect that could lead to inaccurate diagnostic data, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Sendx Medical Inc. is recalling 767 units of the ABL80 FLEX CO-OX analyzer, model #393-841. The recall affects all units with software versions 1.30, 1.31, 1.32, 1.33, and 1.34. The ABL80 FLEX CO-OX is a portable, automated analyzer used by trained medical professionals to measure pH, blood gases, electrolytes, glucose, and oximetry in whole blood.
The recall was initiated because the manufacturer became aware of a software issue related to the reporting of hemoglobin fractional parameters. The affected devices were distributed worldwide, including in the United States (specifically Ohio) and in Switzerland, Germany, France, Poland, Austria, Italy, Japan, Australia, Denmark, China, Sweden, Norway, Spain, the United Kingdom, the Netherlands, and the Czech Republic.
Healthcare facilities and users should stop using the affected analyzers and contact Sendx Medical Inc. for further instructions on the recall.
The recalled product
- 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…
- Manufacturer
- Sendx Medical Inc
- Affected units
- 767
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Serial Numbers: all ABL80 FLEX CO-OX analyzers with sofware versions 1.30
- 1.31
- 1.32
- 1.33
- and 1.34.
Distribution
Distributed in 1 state:
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