Direct Bilirubin Reagents — Class II medical device recall Z-1425-2020
Terminated recall by Beckman Coulter Inc, reported 2020-03-11, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol)
| Recall number | Z-1425-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc, Carlsbad, CA, United States |
| Recall initiated | 2019-08-15 |
| Classified | 2020-03-02 |
| Reported by FDA | 2020-03-11 |
| Terminated | 2024-02-28 |
| Distributed | 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 |
| Countries outside the US | AE, AU, BD, BE, BG, CA, CH, CN, CW, CZ, DE, EG, ES, FI, FR, GB, GH, GR, GT, GY, HK, IE, IN, IT, JP, KR, KW, LB, LT, MX, MY, NL, OM, PA, PH, PL, PT, PY, QA, RO, RS, RU, SA, SG, TH, TN, TR, TW, VN, ZA |
| Quantity | 17,824 reagents |
| UPC / GTIN / UDI-DI | 15099590575120, 15099590625603 |
| Model numbers | 439715 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1425-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.