Medica Corporation: Medical Device Recall in 2018 - (Recall #: Z-1267-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 11, 2017

Date Posted: April 4, 2018

Recall Number: Z-1267-2018

Event ID: 77160

Reason for Recall:

Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.

Status: Terminated

Product Quantity:

Code Information:

Medica s Lot # 16292

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated