Recall Z-1425-2020 ยท CIG Diazo Colorimetry, Bilirubin
Beckman Coulter Inc
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)
| Date | Aug 15, 2019 |
| Status | Terminated |
| 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 to |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934068 | BECKMAN DIRECT BILIRUBIN REAGENT Beckman-Diagnostic Systems Group, Apr 26, 1994 |