FDA Medical Device Recalls (openFDA)
Diamedix Corporation: Diamedix Is-CMV IgG Test Kit
- Recall number
- Z-1689-2016
- Recalling firm
- Diamedix Corporation
- Product
- Diamedix Is-CMV IgG Test Kit
- Status
- Terminated
- Initiated
- 2015-03-26
- Posted
- not on file
- Terminated
- 2018-11-14
- Reason
- Product contained an incorrect substrate.
- Root cause
- Other
- Action
- On March 26, 2015 Erba Diagnostics sent a communication to their clients informing them of the recall and sending t hem a replacement sustrate HRP to replaced the wrong one sent on the kit.
- Quantity
- 150 kits
- Distribution
- AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico.
- Lot, serial or model codes
- Catalog # 720-320 Lot # 10105 Expiration Date January 31, 2016
- 510(k) numbers
- ["K981163"]
- PMA numbers
- not on file
- Product code
- LFZ
- 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