A1CNow+ Multi-Test HbA1c System recalled due to mismatched cartridge and analyzer codes
Polymer Technology Systems recalled 2,452 A1CNow+ diabetes test systems due to mismatched cartridge and analyzer codes. Non-matching components may produce inaccurate blood glucose readings.
What this means for you
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: FDA Class II recall of a medical device used for diabetes monitoring. No hospitalizations, illnesses, or deaths have been reported. However, non-matching components could result in inaccurate blood glucose readings that may lead to inappropriate diabetes therapy adjustments, meeting the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
The A1CNow+ Multi-Test HbA1c System, manufactured by Polymer Technology Systems, Inc., consists of a monitor device, reagent cartridge, and blood sample collection kit. The FDA is recalling 2,452 units distributed worldwide due to complaints of non-matching cartridge and analyzer codes found within product boxes.
Each lot number's components are designed to work together. When cartridges and analyzers with different codes are mixed between lots, the system can produce inaccurate Hemoglobin A1C test results. These errors may result in falsely high readings that could indicate a need for increased diabetes therapy, or falsely low readings that could result in under-treatment.
The recall affects units distributed in the United States, Japan, and South Africa (Lot Numbers 9331803 and 2323019). Patients and healthcare providers who have used this system should verify that cartridge and analyzer codes match before use. Users should contact Polymer Technology Systems with questions about whether their units are affected.
The recalled product
- Product
- A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution
- Manufacturer
- Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
- Hazard
- component-mismatch
- inaccurate-results
- incorrect-therapy-risk
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 (2)
- UDI-DI: 00381933021011 Lot Numbers: 9331803
- 2323019
Distribution
Distributed nationwide across the United States.
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