Recall Z-3118-2017— Beckman Coulter Inc.

Name: FDA recall Z-3118-2017
Creator: U.S. Food and Drug Administration
Published: 2017-07-20

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-07-20, terminated 2018-01-04. It names one FDA 510(k) clearance: K081938. 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.. 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..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-07-20
Terminated: 2018-01-04
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K081938 — ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30Genzyme Diagnostics P.E.I., Inc.·cleared 2009-05-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.