FDA Medical Device Recalls (openFDA)
Meridian Bioscience Inc: Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G.
- Recall number
- Z-1127-03
- Recalling firm
- Meridian Bioscience Inc
- Product
- Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G.
- Status
- Terminated
- Initiated
- 2003-06-18
- Posted
- 2003-08-12
- Terminated
- 2004-03-29
- Reason
- The Low Positive Standard kit component is losing potency that may result in false positive test results.
- Root cause
- Other
- Action
- The firm notified their customers by telephone and fax on 6/18/2003.
- Quantity
- 43 kits
- Distribution
- The kits were shipped to end-users located in CA, UT, NY, MD, KY; and to a foreign distributor in Belgium.
- Lot, serial or model codes
- Lot Numbers: #03022371 and #03022472. All lots Exp Date: 2004-07.
- 510(k) numbers
- ["K924096"]
- PMA numbers
- not on file
- Product code
- LFZ
- Firm FEI
- 1524213
- Firm city
- Cincinnati
- Firm state
- OH
- 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