Recall Z-1267-2018— Medica Corporation

Name: FDA recall Z-1267-2018
Creator: U.S. Food and Drug Administration
Published: 2017-04-11

Class II · Terminated

Class II FDA medical device recall by Medica Corporation, initiated 2017-04-11, terminated 2019-08-20. It names one FDA 510(k) clearance: K120497. 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: Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values..

Recalling firm: Medica Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-04-11
Terminated: 2019-08-20
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K120497 — EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIALMedica Corp.·cleared 2012-05-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.