Polymer Technology Systems Recalls A1CNow+ Systems Due to Software Bug
Polymer Technology Systems is recalling A1CNow+ Systems because a software bug may display incorrect numerical values instead of expected symbols.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a software display error without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Polymer Technology Systems is recalling A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058. The recall involves 112,648 units.
The recall is being conducted because a software bug may cause the device to display a numerical value less than 4% or greater than 13% instead of the expected <4% or >13% result. This error could lead to misinterpretation of test results.
The products were distributed to 18 US states and Puerto Rico, as well as 38 foreign countries. Affected lot numbers are listed in the source document. Users should stop using the affected software version and contact Polymer Technology Systems for instructions.
The recalled product
- Product
- A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058
- Manufacturer
- Polymer Technology Systems
- Hazard
- Affected units
- 112,648
Distribution
Part of a larger recall action
This product is one of 5 recalled by Polymer Technology Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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