FDA Medical Device Recalls (openFDA)
PerkinElmer LIfe Sciences Inc: Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.
- Recall number
- Z-0898-03
- Recalling firm
- PerkinElmer LIfe Sciences Inc
- Product
- Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.
- Status
- Terminated
- Initiated
- 2003-01-08
- Posted
- 2003-05-29
- Terminated
- 2008-09-13
- Reason
- The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.
- Root cause
- Other
- Action
- The firm notified their customers by letter on 1/8/2003.
- Quantity
- 75 Kits
- Distribution
- The kits were shipped to three (3) State Departments of Health in WI, AR, and MI.
- Lot, serial or model codes
- Lot #115496, Exp. 11/1/03
- 510(k) numbers
- ["K950803"]
- PMA numbers
- not on file
- Product code
- JJT
- 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