Z-1425-2020Class II

Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856...

Name: Z-1425-2020 Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856...
Creator: Beckman Coulter Inc
Published: 2019-08-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-08-15 / Terminated / root cause: design

FDA source

Beckman Coulter Inc began a recall of Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use... on 2019-08-15. FDA classified it as Class II and gives the reason as "It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1425-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-15
Posted: 2020-03-02
Terminated: 2024-02-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/cartridge) and 15099590625603(300 tests/cartridge)
Product code: CIG Diazo Colorimetry, Bilirubin
Reason for recall: It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.
Root cause tag: design
FDA root cause: Device Design
Action: On August 15, 2019, the firm mailed or emailed a "Urgent Medical device Recall" to affected consignees In addition to informing the consignees about the recall, they ask consignees to do the following: 1. Resolution: The following statement will be added to the Interfering Substances section of the Enzymatic Creatinine, Triglycerides GPO Blanked, Uric Acid, Direct Bilirubin, and Total Bilirubin Chemistry Information Sheets (CIS): N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may generate erroneously low results in samples for patients that have taken toxic doses of acetaminophen (paracetamol). 2. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. 3. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email. " Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support Center; " From our website: http://www.beckmancoulter.com " By phone: call 1-800-854-3633 in the United States and Canada. " Outside the United States and Canada, contact your local Beckman Coulter representative.
Quantity in commerce: 17,824 reagents
Distribution: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine,Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming, Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas,Utah,Virginia,Washington,West Virginia, Wisconsin,Wyoming Australia, Bangladesh, Belgium, Brunei, Bulgaria, Canada, China, Curacao, Czech Republic, Egypt, Eritrea, Finland, France, Germany, Ghana, Greece, Guatemala, Guyana, Hong Kong, India, Ireland, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mayotte, Mexico, Netherlands, Oman, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Swaziland, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam
Product codes and lots: All Lot Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1425-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1422-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-02
Z-1423-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-02
Z-1424-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-02
Z-1425-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-02
Z-1426-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-02

Product code CIG

K934068Class IIBeckman Direct Bilirubin ReagentBeckman-Diagnostic Systems Group / cleared 1994-04-26

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)