Food, drugs, devices › Medica Corporation
Device recall: EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for ea
Medica Corporation (Bedford, MA) initiated this device recall on 11 Apr 2017; FDA lists 1 product record under event 77160, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 20 Aug 2019. Initiation: voluntary: firm initiated. Medica Corporation has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medica Corporation, Bedford, MA.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1267-2018 | 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. | — | Class II | Terminated | 4 Apr 2018 |
Context
Other enforcement events for Medica Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 31 Dec 2025 | Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit. | Device | Class II | 1 |
| 6 Feb 2019 | Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usag | Device | Class II | 1 |
| 21 Nov 2017 | Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # | Device | Class II | 1 |
All 4 events for Medica Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Aug 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.