FDA Medical Device Recalls (openFDA)
PerkinElmer Life Sciences Inc: Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100.
- Recall number
- Z-1139-03
- Recalling firm
- PerkinElmer Life Sciences Inc
- Product
- Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100.
- Status
- Terminated
- Initiated
- 2003-06-27
- Posted
- 2003-08-20
- Terminated
- 2008-10-24
- Reason
- The kits are producing lower values than expected, which may result in an increase of false positive test results.
- Root cause
- Other
- Action
- The firm contacted their customers by telephone and fax on 6/27/03 and 7/1/03.
- Quantity
- 85 kits
- Distribution
- The kits were shipped to ten (10) State Health Laboratories in AL, CT, AZ, CO, FL, IN, LA, MO, NJ, OH.
- Lot, serial or model codes
- Lot #164738
- 510(k) numbers
- ["K950803"]
- PMA numbers
- not on file
- Product code
- JLJ
- 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