Severity
Moderate
ModerateClass IICompleted
FDA Devices recall · Reported October 30, 2024
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 the sample to the cartridge.
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 anal…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Polymer Technology Systems, Inc. dba Pts Diagnostics, Inc. recalled A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device … - a moderate-severity action.
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device … was recalled by Polymer Technology Systems, Inc. dba Pts Diagnostics, Inc. in October 30, 2024. Reason: The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyze…. Check the official notice for the remedy. Verify recall #Z-0223-2025 with the FDA Devices before acting.
The recall
Polymer Technology Systems, Inc. dba Pts Diagnostics, Inc. issued this moderate-severity FDA Devices recall-The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyze….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- October 30, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0223-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0223-2025) was formally reported on October 30, 2024, with the manufacturer initiating the action on September 18, 2024. It is classified under Moderate severity (Class II), with a current status of Completed. Polymer Technology Systems, Inc. dba Pts Diagnostics, Inc. is listed as the recalling firm, operating out of Whitestown, IN. Federal records list the affected scope as 2,452 units.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Japan, South Africa.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2,452 units
Related Recalls
6
3 from same agency
Product description
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 the sample to the cartridge.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | Z-0223-2025 |
| Date reported | October 30, 2024 |
| Date initiated | September 18, 2024 |
| Recalling firm | Polymer Technology Systems, Inc. dba Pts Diagnostics, Inc. |
| Firm location | Whitestown, IN |
| Affected scope | 2,452 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Japan, South Africa. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0223-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 the sample to the cartridge.. Recalled by Polymer Technology Systems, Inc. dba Pts Diagnostics, Inc.. Units affected: 2,452 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2024. Severity: Moderate. Recall number: Z-0223-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Japan, South Africa..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0223-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 30, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.