CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report
EasyCAL HbA1c Calibrator recalled by Medica
Medica is recalling EasyCAL HbA1c Calibrator, distributed in California, Florida, Michigan, Puerto Rico, Texas. The recall was initiated on 11 Apr 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1267-2018
- FDA event ID
- 77160
- Recalling firm
- Medica, Bedford, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Apr 2017
- FDA classified
- 28 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 11 Apr 2017 | Recall initiated by company | |
| 28 Mar 2018 | Classified by FDA | +351 days |
| 4 Apr 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.
Questions about this recall
Why was it recalled?
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Which lots are affected?
Medica s Lot # 16292
Where was it sold?
USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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