FDA Medical Device Recalls (openFDA)
PerkinElmer Life Sciences Inc: Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays.
- Recall number
- Z-0970-03
- Recalling firm
- PerkinElmer Life Sciences Inc
- Product
- Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays.
- Status
- Terminated
- Initiated
- 2003-05-30
- Posted
- 2003-07-02
- Terminated
- 2008-10-24
- Reason
- The device is not stable throughout its labeled expiration date.
- Root cause
- Other
- Action
- The firm contacted their customers by telephone and facsimile on 5/30/2003.
- Quantity
- 91 kits
- Distribution
- Nationwide. The product was also shipped to foreign distributors and end-users located in Brazil, Costa Rica, Mexico, Finland, Venezuela, Taiwan, and Korea.
- Lot, serial or model codes
- Lots: #112785, Exp 6/14/03; and #116002, Exp 7/4/03.
- 510(k) numbers
- ["K950481"]
- PMA numbers
- not on file
- Product code
- JIA
- Firm FEI
- 1522510
- Firm city
- Norton
- 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