Reported Oct 30, 2024 · Completed
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic…
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. · 4600 Anson Blvd · Whitestown, IN · 46075-4489
Is this the product you have?
- 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 forcollecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge
- Lot codes and dates
- UDI-DI00381933021011
- Lot Numbers
93318032323019
- Amount recalled
- 2,452 units
Where it was sold
- Nationwide
Why it was recalled
The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot number are meant to be used together, and not mixed between lots. Therefore, the test results may possibly lead to Hemoglobin A1C positive or negative bias results. While the product is for monitoring only, over recovery with a higher than accurate value can be an indication for increased therapy; such as physical activity, weight reduction, meal management, pharmaceutical therapy.
This product could cause temporary or reversible health problems — stop using it.
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