Synchron Systems Opiate 2000 ng Reagent — Class II medical device recall Z-1751-2020
Terminated recall by Beckman Coulter Inc., reported 2020-04-29, distributed nationwide. Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. T
| Recall number | Z-1751-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2019-09-04 |
| Classified | 2020-04-20 |
| Reported by FDA | 2020-04-29 |
| Terminated | 2021-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 1,610 units |
| UPC / GTIN / UDI-DI | 15099590222031 |
| Lot numbers | M904147, OP2 |
| Model numbers | 475006 |
Product
Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in urine.
Reason for recall
Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.
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-1751-2020. 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.