FDA Medical Device Recalls (openFDA)
Diamedix Corporation: Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
- Recall number
- Z-2574-2018
- Recalling firm
- Diamedix Corporation
- Product
- Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
- Status
- Terminated
- Initiated
- 2018-01-05
- Posted
- not on file
- Terminated
- 2019-11-05
- Reason
- Contains a gel-like contaminant that may affect product performance.
- Root cause
- Under Investigation by firm
- Action
- Diamedix sent a letter dated January 5th, 2018 was sent to all their customer with the following: Products contains a gel-like contaminant that may affect product performance.An inspection of the product in the Diamedix inventory confirmed this observation. Although, no failed runs have been directly attributed this issue, we feel that the best course of action is to replace the affected diluent. If you are using the reagent lot specified above, please discontinue use immediately. In order to process your replacement, please complete the attached Certificate of Destruction and return this document to Diamedix Customer Service via email: CustomerService@erbadiagnostics.com or fax to (305) 418- 2321. If you have further questions or concerns you may contact our Technical Service Department at (305) 324-2307 or (800) 433-0945. Please be assured that Diamedix Corporation is working diligently to resolve the issues with this product. We apologize for any inconvenience that this may have caused and we thank you for your continued patience and support. Sincerely, Tracy Chadwrick Director, QA/QC
- Quantity
- 147
- Distribution
- AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI
- Lot, serial or model codes
- Lot T0006 Exp. 05/31/2018
- 510(k) numbers
- ["K981831"]
- PMA numbers
- not on file
- Product code
- GNP
- Firm FEI
- 1044713
- Firm city
- Miami Lakes
- Firm state
- FL
- 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