Beckman Coulter Inc.: Medical Device Recall in 2017 - (Recall #: Z-3118-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 20, 2017

Date Posted: September 20, 2017

Recall Number: Z-3118-2017

Event ID: 77896

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.

Status: Terminated

Product Quantity: 320 units

Code Information:

All lots

Distribution Pattern:

Distribution US nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated