Perkin Elmer 226 Sample Collection Device — Class II medical device recall Z-0030-2014
Terminated recall by Perkin Elmer Health Sciences, Inc., reported 2013-10-30. Some devices may be contaminated on the back side of the device with glue in the blood application area.
| Recall number | Z-0030-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Perkin Elmer Health Sciences, Inc., Greenville, SC, United States |
| Recall initiated | 2013-09-05 |
| Classified | 2013-10-18 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2014-07-17 |
| Quantity | 65,984 devices |
| Serial numbers | 06132903, 06198900 |
Product
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Reason for recall
Some devices may be contaminated on the back side of the device with glue in the blood application area.
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-0030-2014. 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.