FDA Medical Device Recalls (openFDA)
PerkinElmer Life and Analytical Sciences, Wallac, OY: 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
- Recall number
- Z-1220-2018
- Recalling firm
- PerkinElmer Life and Analytical Sciences, Wallac, OY
- 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
- Status
- Terminated
- Initiated
- 2017-09-25
- Posted
- not on file
- Terminated
- 2018-09-06
- Reason
- The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.
- Root cause
- Process control
- Action
- Actions to be taken: Inspect your inventory of AutoDELFIA Neonatal IRT kits for batch number 1065647901 and replace the Quality Control Certificate included in the kit packaging with the revised certificate attached to this letter. If you have already used the kit lot there is no need to retest the samples reported if the results of the controls included in the assay were within your established acceptance range. Complete and return the enclosed response form identifying the quantity of affected kits in your possession. Please inform others affected in your organization accordingly. To comply with regulatory requirements we require that you complete the enclosed Response Form and return it.
- Quantity
- 240
- Distribution
- Distributed to CT and TX.
- Lot, serial or model codes
- Lot Number: 656479, Batch Number: 1065647901, Expiration date: 2019-4-30
- 510(k) numbers
- ["K110274"]
- PMA numbers
- not on file
- Product code
- JNO
- Firm FEI
- 3002808498
- Firm city
- Turku
- Firm state
- not on file
- Firm country
- Finland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28