AutoDELFIA Neonatal IRT Kit Recalled for Missing Quality Control Certificate Information
PerkinElmer is recalling AutoDELFIA Neonatal IRT kits because missing quality control certificate information may delay reporting of IRT results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, and the source text identifies the issue as missing documentation (Quality Control Certificate) that may delay results, which aligns with the rubric criteria for documentation issues and cosmetic/packaging-only problems.
Plain-English summary
PerkinElmer Life and Analytical Sciences, Wallac, OY is recalling 240 units of the AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, Product Number B005-212. The affected lot number is 656479, batch number 1065647901, with an expiration date of April 30, 2019. The product was distributed to Connecticut and Texas.
The recall was initiated because the Quality Control Certificate for these kits is missing information required to assess the acceptability of measured control values. This deficiency may result in a delay in reporting IRT results. The kits are intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens.
Healthcare facilities and laboratories that have received these kits should stop using them and contact the recalling firm for instructions on return or replacement. Consumers should not use these kits for diagnostic purposes.
The recalled product
- Product
- AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
- Affected units
- 240
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)
- Lot Number: 656479
- Batch Number: 1065647901
- Expiration date: 2019-4-30
Distribution
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