FDA Medical Device Recalls (openFDA)
Medica Corporation: 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 wedge is used to prevent interference between certain tests.
- Recall number
- Z-1294-2019
- Recalling firm
- Medica Corporation
- Product
- 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 wedge is used to prevent interference between certain tests.
- Status
- Terminated
- Initiated
- 2019-02-06
- Posted
- not on file
- Terminated
- 2020-10-02
- 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.
- Root cause
- Process design
- Action
- Medica issued letters dated 2/8/19 via email Bulletin B1901 & B1902 to distributors and end-users on record. Letter describes problem, action to be taken: Immediately discontinue use of the Wash1 wedges (REF 10680) and discard any remaining kits/wedges. Complete the response form. Discuss possible concerns about Lipase results achieved using these lots of Wash wedges with your laboratory manager and/or clinician in order to decide on appropriate measures. Report any concerns to Medica for evaluation and review. Questions contact Medica Technical Support at (877) 777-5895 or via email at: EasyRAtech@medicacorp.com.
- Quantity
- 87 kits
- Distribution
- Worldwide distribution - US Nationwide and countries of IRAQ, FRANCE, INDIA, GEORGIA, GEORGIA, FRANCE GUATEMALA, KENYA, IRAN, ESTONIA.
- Lot, serial or model codes
- Lot #s 18066, 18133, 18235, 18317
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CHI
- Firm FEI
- 1220972
- Firm city
- Bedford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28