FDA Device recall Z-0688-2013
NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galact…
- FDA Device
- Class II
- terminated
- Published 2013-01-23
On 2013-01-23 the FDA classified a Class II recall of NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galact… by Perkinelmer, citing truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0688-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-26 |
| Published | 2013-01-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Perkinelmer |
| Distribution | US |
Product
NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
Reason
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Identifiers
| code_info | Lot Numbers: 618201, 619200, 618263 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0688-2013%22
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