FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
- Recall number
- Z-1422-2020
- Recalling firm
- Beckman Coulter Inc
- Product
- Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
- Status
- Terminated
- Initiated
- 2019-08-15
- Posted
- not on file
- Terminated
- 2024-02-28
- Reason
- 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
- 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
- 2581 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
- Lot, serial or model codes
- All Lot Numbers
- 510(k) numbers
- ["K091742"]
- PMA numbers
- not on file
- Product code
- JFY
- Firm FEI
- 2050010
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28