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Terminated

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 Recall Z-3118-2017 · Posted None

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeLDP
Date Initiated2017-07-20
Date Terminated2018-01-04
Product Quantity320 units

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.

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distribution US nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081938ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30Genzyme Diagnostics P.E.I., Inc. · 2009-05-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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