# FDA recall Z-1267-2018

> **Medica Corporation** · Class II · device recall initiated 2017-04-11.

## Product

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.

## Distribution

USA: MI  FL  CA  TX    India, Russia, Puerto Rico, N. Mariana Island/Palau.

## Key facts

- **Recall number:** Z-1267-2018
- **Recalling firm:** Medica Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-04-11
- **Report date:** 2018-04-04
- **Termination date:** 2019-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bedford, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1267-2018

## Citation

> AI Analytics. FDA recall Z-1267-2018. Retrieved 2026-06-22 from https://api.ai-analytics.org/recall/Z-1267-2018. Source: US FDA. Licensed CC0.

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