Synchron 475006Recalls & reported problems
Beckman Coulter, Inc. · Opiate 2000 ng Reagent (OP2 1 x 250) · Class 2
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Sep 4, 2019Terminated
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.
Z-1751-2020 · Root cause: Material/Component Contamination · FDA record ↗
Other Enzyme Immunoassay, Opiates devices
- VITROS 6801997Ortho-Clinical Diagnostics, Inc. · ENZYME IMMUNOASSAY, OPIATES1 recall0 reports
- Wondfo Drug Test Dip Card WDBU-114Wondfo USA CO., Ltd. · Enzyme Immunoassay, Opiates1 recall0 reports
- Synchron 475024Beckman Coulter, Inc. · Enzyme Immunoassay, Opiates1 recall0 reports
- U-Screen USSCupA-12BUP300Instant Tech Subsidiary Acquisition · Enzyme Immunoassay, Opiates1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.