Recall Z-1220-2018— PerkinElmer Life and Analytical Sciences, Wallac, OY

Name: FDA recall Z-1220-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-25

Class III · Terminated

Class III FDA medical device recall by PerkinElmer Life and Analytical Sciences, Wallac, OY, initiated 2017-09-25, terminated 2018-09-06. It names one FDA 510(k) clearance: K110274. 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. 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..

Recalling firm: PerkinElmer Life and Analytical Sciences, Wallac, OY
Classification: Class III
Status: Terminated
Initiated: 2017-09-25
Terminated: 2018-09-06
Firm location: Turku, N/A, Finland

510(k) clearances named in this recall

1 on FDA's record

K110274 — AUTODELFIA NEONATAL IRT KITWallac Oy, A Subsidiary of Perkinelmer, Inc.·cleared 2011-06-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.