Perkin Elmer 226 Sample Collection Device Recall for Glue Contamination
Perkin Elmer is recalling 226 Sample Collection Devices used for newborn screening due to potential glue contamination on the back side.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a physical contamination (glue) rather than a high-risk pathogen or structural defect, and no injuries or illnesses are reported in the source text.
Plain-English summary
Perkin Elmer Health Sciences, Inc. is recalling 65,984 Perkin Elmer 226 Sample Collection Devices. These devices are used to collect and transport whole blood specimen spots to a laboratory for newborn screening. The recall covers serial numbers 06132903 through 06198900, associated with Job number 313119 and Item Lot number Ohio HEA 2518.
The recall is being issued because some devices may be contaminated on the back side of the device with glue in the blood application area. The devices were distributed in Ohio, United States.
Healthcare providers and laboratories should stop using the affected devices and contact Perkin Elmer Health Sciences, Inc. for instructions on how to return or dispose of them.
The recalled product
- 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…
- Manufacturer
- Perkin Elmer Health Sciences, Inc.
- Hazard
- Affected units
- 65,984
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Job number: 313119
- Item Lot number: Ohio HEA 2518
- Serial numbers: 06132903 - 06198900.
Distribution
Distributed in 1 state:
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