Triglycerides Reagent — Class II medical device recall Z-1423-2020

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-1423-2020`
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
UPC / GTIN / UDI-DI	`15099590233228`
Model numbers	`445850`

Product

Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228

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-1423-2020. 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.