SYNCHRON Systems Barbiturates Reagent — Class II medical device recall Z-1799-2020
Terminated recall by Beckman Coulter Inc., reported 2020-05-06, distributed nationwide. The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Re
| Recall number | Z-1799-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2019-06-12 |
| Classified | 2020-04-24 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2020-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 10,145 units |
| UPC / GTIN / UDI-DI | 15099590223007 |
| Lot numbers | M801045, M802093, M803040, M804028, M805116, M806172, M807116, M809230, M811093, M902167, M903174 |
| Model numbers | 475012 |
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 for recall
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.
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-1799-2020. 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.