Recall Z-1220-2018 ยท JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
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
| Date | Sep 25, 2017 |
| Status | Terminated |
| 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 |
| Quantity | 240 |
| Distribution | Distributed to CT and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110274 | AUTODELFIA NEONATAL IRT KIT Wallac Oy, A Subsidiary of Perkinelmer, Inc., Jun 10, 2011 |