Clinical Chemistry — Class II medical device recall Z-0119-2020
Terminated recall by Horiba Instruments Incorporated, reported 2019-10-16, distributed in AL, AZ, CA, CO, CT, FL, GA, IA…. Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Ch
| Recall number | Z-0119-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Horiba Instruments Incorporated, Irvine, CA, United States |
| Recall initiated | 2018-10-30 |
| Classified | 2019-10-10 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2020-06-16 |
| Distributed | AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY |
| Quantity | 1,539 chemistry |
| Reason classes | chemical contamination |
| UPC / GTIN / UDI-DI | 03610230004944 |
| Model numbers | 1220001631, A11A01631 |
Product
Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
Reason for recall
Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could be observed and a patient result could be declared abnormal by the instrument due to these interferences instead of normal result < 38 U/L (or < reference value used in your laboratory).
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-0119-2020. 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.