Device product
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.
Z-3118-2017
Product summary
- Event
- Event 77896
- Status
- Terminated
- Classification
- Class II
- Quantity
- 320 units
- Official record key
device-enforcement:Z-3118-2017
Official wording
Reason: 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.
Code information: All lots
Distribution pattern: Distribution US nationwide.
Derived failure modes
-
Unknown
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.