FDA Device recall Z-1752-2020
Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators,…
- FDA Device
- Class II
- terminated
- Published 2020-04-29
On 2020-04-29 the FDA classified a Class II recall of Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators,… by Beckman Coulter, citing cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result in false positive o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1752-2020 |
| 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
Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.
Reason
Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)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 475024; UDI:15099590222970 ; Lot Numbers: M904130 and older including M802097, M803045, M804024, M80512…Catalog Number 475024; UDI:15099590222970 ; Lot Numbers: M904130 and older including M802097, M803045, M804024, M805123, M806080, M808069, M809218, M810293, M901044, M902086, and M903175. . |
|---|
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-1752-2020%22
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