FDA Devices recall · Reported April 4, 2018
EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Medica Corporation recalled EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of… - a moderate-severity action.
EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of… was recalled by Medica Corporation in April 4, 2018. Reason: Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate fal…. Check the official notice for the remedy. Verify recall #Z-1267-2018 with the FDA Devices before acting.
The recall
Medica Corporation issued this moderate-severity FDA Devices recall-Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate fal….
- Moderate
- severity level
- Class II
- classification
- April 4, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1267-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts. 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
EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.
Reason for recall
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1267-2018 |
| Date reported | April 4, 2018 |
| Date initiated | April 11, 2017 |
| Recalling firm | Medica Corporation |
| Firm location | Bedford, MA |
| Affected scope | Not disclosed |
| Distribution | USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau. |
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-1267-2018) 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