Reported May 6, 2020 · Terminated
SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 -
- Product UsageBARB 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
- Lot codes and dates
SYNCRHON Systems BARB 1 X 250)Catalog No. 475012
- UDI
15099590223007Lot Numbers M903174M902167M801045M811093M809230M807116M806172M805116M804028M803040M802093 and older
- Amount recalled
- 10,145 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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