FDA Medical Device Recalls (openFDA)
PerkinElmer LAS Inc: Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.
- Recall number
- Z-1499-04
- Recalling firm
- PerkinElmer LAS Inc
- Product
- Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.
- Status
- Terminated
- Initiated
- 2004-09-08
- Posted
- 2004-09-30
- Terminated
- 2008-10-29
- Reason
- There is an increase in the number of normal specimen results below the lowest calibrator and based on a report that the normal controls were running low, sometimes out of the specified range.
- Root cause
- Other
- Action
- The firm contacted their consignees by letter sent 9/8/04.
- Quantity
- 49 kits
- Distribution
- The kits were distributed to 5 consignees, located in Indianapolis, IN; Jefferson City, MO; Austin, TX; Madison, WI; and Minneapolis, MN.
- Lot, serial or model codes
- Lot #244468
- 510(k) numbers
- not on file
- 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