FDA Device recall Z-1425-2020
Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vit…
- FDA Device
- Class II
- terminated
- Published 2020-03-11
On 2020-03-11 the FDA classified a Class II 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 Vit… by Beckman Coulter, citing 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 quant….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1425-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-15 |
| Published | 2020-03-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Beckman Coulter |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY |
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)
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.
Identifiers
| code_info | All Lot Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1425-2020%22
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