Abaxis Recalls Piccolo Xpress Chemistry Analyzers Due to Incorrect Reference Ranges
Abaxis Inc is recalling 15 Piccolo Xpress chemistry analyzers because they display incorrect reference ranges for analytes, which may affect test result interpretation.
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 is classified as FDA Class II, and the hazard involves incorrect reference ranges which could lead to misinterpretation of medical test results, fitting the criteria for a High severity rating where risk of harm exists but no specific injuries are reported in the source text.
Plain-English summary
Abaxis Inc is recalling 15 units of the Piccolo Xpress chemistry analyzer, Model No. 1100-1001, due to incorrect reference ranges for analytes. The affected units are equipped with Software version 2.1.55 (NGA) or 3.1.35 (Jen II). The recall is classified as Class II by the U.S. Food and Drug Administration.
The distribution of the recalled units includes consignees in Texas, Pennsylvania, Florida, Oklahoma, Kentucky, California, and Virginia. No units were distributed outside the United States. The recall covers specific serial numbers listed in the agency's documentation.
The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences. Users of these devices should contact Abaxis Inc for instructions on how to proceed, as the incorrect reference ranges may lead to misinterpretation of chemistry test results.
The recalled product
- Product
- Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
- Manufacturer
- Abaxis Inc
- Affected units
- 15
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 (3)
- Model Number: 1100-0000
- 1100-0001
- 0000000P02700 0000000P22997
Distribution
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