FDA Medical Device Recalls (openFDA)
Perkinelmer Life Sciences, Inc.: Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103
- Recall number
- Z-1140-03
- Recalling firm
- Perkinelmer Life Sciences, Inc.
- Product
- Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103
- Status
- Terminated
- Initiated
- 2003-07-21
- Posted
- 2003-08-20
- Terminated
- 2003-11-19
- Reason
- Product's outer carton label was labeled with an extended expiration date
- Root cause
- Other
- Action
- PerkinElmer notified customers by telephone on 7/21/2003 of the expiration date error on the outer carton label . A recall letter issued on 7/25/03 and a verification form was requested to be completed and returned.
- Quantity
- 69 kits
- Distribution
- CA, PA, IN, MO Foreign: Switzerland
- Lot, serial or model codes
- Lot Number: 181578
- 510(k) numbers
- ["K843347"]
- PMA numbers
- not on file
- Product code
- DHN
- Firm FEI
- 1000513616
- Firm city
- Boston
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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