A1CNow+ Multi-Test HbA1c System consists of recall
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent…
Why was A1CNow+ Multi-Test HbA1c System consists of 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00381933021011 Lot Numbers: 9331803, 2323019
- Product
- A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent…
- Recalling firm
- Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
- Quantity
- 2,452 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Japan, South Africa.
- Recall date
- October 30, 2024
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)