—#158164

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.

FDA product code: LDP — Colorimetry, Acetaminophen
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K081938
Affected lot / code info: All lots

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The recalling firm issued letters dated 7/17/2017 via regular mail and email on 7/20/2017 to all customers receiving the affected product.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Distribution US nationwide.

Timeline

Recall initiated: 2017-07-20
Terminated: 2018-01-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #158164. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.