Bedford, MA, United States
Medica Corporation recalls
4 recalls recorded since 2018, most recently on 31 December 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 31 December 2025
- Reason
- A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
- Distribution
- International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1370-2026
- Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Terminated Class II Medical devices
- Recall started
- 6 February 2019
- Terminated
- 2 October 2020
- Reason
- Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.
- Distribution
- Worldwide distribution - US Nationwide and countries of IRAQ, FRANCE, INDIA, GEORGIA, GEORGIA, FRANCE GUATEMALA, KENYA, IRAN, ESTONIA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1294-2019
- Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the
Terminated Class II Medical devices
- Recall started
- 21 November 2017
- Terminated
- 20 August 2020
- Reason
- The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyzing patient samples. The firm's internal investigation identified the underlying cause to be an ineffective wash solution resulting in an interference carryover from the triglyceride (TRIG) assay if they are on the same worklist.
- Distribution
- Worldwide and US Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1149-2018
- Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a
Terminated Class II Medical devices
- Recall started
- 11 April 2017
- Terminated
- 20 August 2019
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.