Z-3118-2017 Class II Terminated
FDA device recall Z-3118-2017 was initiated by Beckman Coulter Inc. on July 20, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated January 4, 2018). Affected quantity: 320 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2017
- Initiation Date
- July 20, 2017
- Termination Date
- January 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 320 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Distribution US nationwide.
Code Information
All lots