FDA Medical Device · Z-3118-2017

Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.

Class II · Terminated

Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.

Affected lots / codes — check yours against thisAll lots

Recalling firm: Beckman Coulter Inc., Brea, CA
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 320 units
Distribution: Distribution US nationwide.
Recall initiated: July 20, 2017
Classified: September 12, 2017
Terminated: January 4, 2018
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3118-2017%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

Check this brand across all 8 databases →