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, and delivering ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Completed
Brands named
UPCs
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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