FDA Device recall Z-1799-2020
SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250)
- FDA Device
- Class II
- terminated
- Published 2020-05-06
On 2020-05-06 the FDA classified a Class II recall of SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250) by Beckman Coulter, citing the firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The presence of certain comp….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1799-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-12 |
| Published | 2020-05-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of barbiturates in human urine at a cutoff value of 200 ng/mL The BARB assay provides a rapid screening procedure for determining the presence of barbiturates (BARB) and its metabolites in urine.
Reason
The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The presence of certain compounds in urine may result in false positive or false negative results.
Identifiers
| code_info | SYNCRHON Systems BARB 1 X 250); Catalog No. 475012; UDI: 15099590223007; Lot Numbers M903174, M902167, M801045, M811…SYNCRHON Systems BARB 1 X 250); Catalog No. 475012; UDI: 15099590223007; Lot Numbers M903174, M902167, M801045, M811093, M809230, M807116, M806172, M805116, M804028, M803040, M802093 and older. |
|---|
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-1799-2020%22
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