FDA Medical Device Recalls (openFDA)
Zeus Scientific Inc: Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.
- Recall number
- Z-1095-03
- Recalling firm
- Zeus Scientific Inc
- Product
- Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.
- Status
- Terminated
- Initiated
- 2003-06-12
- Posted
- 2003-08-12
- Terminated
- 2006-02-22
- Reason
- The Calibrator included within the kit may be losing reactivity.
- Root cause
- Other
- Action
- All customers were notified via recall letter on June 12, 2003. Letter sent out via Airborne Express. All product is to be returned to Zeus or destroyed.
- Quantity
- 270 kits
- Distribution
- The product was distributed to 6 distributors and 24 direct accounts in the United States and Internationally. Canada; Sweden; Costa Rica; Czech; Indonesia.
- Lot, serial or model codes
- Product Number 9Z9501G Lot Number: 03022371 exp. 2004-July; 03022392 exp. 2004-July; 03022472 exp 2004-July.
- 510(k) numbers
- ["K891081"]
- PMA numbers
- not on file
- Product code
- LFZ
- Firm FEI
- 2242436
- Firm city
- Branchburg
- Firm state
- NJ
- 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