Beckman Coulter Inc.: 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 Drug

Is my product affected?

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 a

• UPC 15099590223007

Check against the official notice below — it lists the full affected range.

What happened

Beckman Coulter Inc. is recalling SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250), Catalog No. 475012, used with UniCel DxC 600/800 Systems for drug testing. The company identified that cross-reactivity testing may not meet the claims in the product's Chemistry Information Sheet, meaning certain compounds in urine samples could produce false positive or false negative results.

Approximately 10,145 units were distributed worldwide, including throughout the United States and multiple countries. The recall affects Lot Numbers M903174, M902167, M801045, M811093, M809230, M807116, M806172, M805116, M804028, M803040, M802093, and older lots. The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: Worldwide distribution - US Nationwide distribution and to multiple countries. Quantity: 10,145 units Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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