FDA Device recall Z-1751-2020
Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250)
- FDA Device
- Class II
- terminated
- Published 2020-04-29
On 2020-04-29 the FDA classified a Class II recall of Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250) by Beckman Coulter, citing 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 positiv….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1751-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-04 |
| Published | 2020-04-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Beckman Coulter |
| Distribution | AL, AR, AZ, CA, CO, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MS, NC, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TX, VA, WA, WI, WV |
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
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.
Identifiers
| code_info | Catalog Number 475006 ; UDI: 15099590222031; Lot Numbers: M904147 and older including M810039, M901087 and M904147) an…Catalog Number 475006 ; UDI: 15099590222031; Lot Numbers: M904147 and older including M810039, M901087 and M904147) and 4 lots OP2 (M805122, M810039, and M901087. . |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1751-2020%22
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