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…
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 recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026