NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010 — Class II medical device recall Z-0688-2013
Terminated recall by Perkinelmer, reported 2013-01-23, distributed nationwide. Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
| Recall number | Z-0688-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Perkinelmer, Waltham, MA, United States |
| Recall initiated | 2012-11-26 |
| Classified | 2013-01-16 |
| Reported by FDA | 2013-01-23 |
| Terminated | 2014-03-07 |
| Distributed | Nationwide (US) |
| Lot numbers | 618201, 618263, 619200 |
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 for recall
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0688-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.