FDA Medical Device Recalls (openFDA)
Perkin Elmer Life and Analytical Sciences Inc: Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000
- Recall number
- Z-0514-04
- Recalling firm
- Perkin Elmer Life and Analytical Sciences Inc
- Product
- Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000
- Status
- Terminated
- Initiated
- 2004-01-09
- Posted
- 2004-07-20
- Terminated
- 2008-10-29
- Reason
- The device is not stable throughout its labeled expiration date.
- Root cause
- Other
- Action
- The firm contacted their customers by letter on 1/9/2004.
- Quantity
- 333 kits
- Distribution
- The kits were shipped to domestic end-users located in NJ, PA, TX, IN, MI, MO, IL, CO, CT, AR, FL, LA, OH, NM, WA.
- Lot, serial or model codes
- Lots #177835, Exp 1/7/04; #178068, Exp 2/7/04; #195324, Exp 2/18/04; #204423, Exp 4/8/04; #207440, Exp 4/29/04; #213466, Exp 5/24/04.
- 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