Z-3118-2017Class II

Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui...

Name: Z-3118-2017 Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui...
Creator: Beckman Coulter Inc.
Published: 2017-07-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-07-20 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and... on 2017-07-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3118-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-20
Posted: 2017-09-12
Terminated: 2018-01-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: LDP Colorimetry, Acetaminophen
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 320 units
Distribution: Distribution US nationwide.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3118-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3118-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12

Product code LDP

K081938Class IIAcetaminophen L3k Assay, and Acetaminophen L3k Assay, Models 506-10, 506-30Genzyme Diagnostics P.E.I., Inc. / cleared 2009-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)