Z-1799-2020Class II

SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 -

Name: Z-1799-2020 SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 -
Creator: Beckman Coulter Inc.
Published: 2019-06-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-06-12 / Terminated

FDA source

Beckman Coulter Inc. began a recall of 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... on 2019-06-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1799-2020
Classification: Class II
Status: Terminated
Initiated: 2019-06-12
Posted: 2020-04-24
Terminated: 2020-12-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: DIS Enzyme Immunoassay, Barbiturate
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.
FDA root cause: Under Investigation by firm
Action: On 06/12/2019, an Urgent Medical Device Recall Letter was sent to customers via first class mail and/or email informing them that the firm has identified, through study results, that cross-reactivity testing may not meet the claims indicated in the Barbiturates Chemistry Information Sheet (CIS). Customers were informed that the presence of the following compounds in urine may lead to false negative results: Barbital at a concentration of 1500 to ~1700 ng/mL; Butabarbital at a concentration of 250 to ~300 ng/mL; Butalbital at a concentration of 400 to ~500 ng/mL; Diallybarbital at a concentration of 600 to ~700 ng/mL; Pentobarbital at a concentration of 500 to ~600 ng/mL; Phenobarbital at a concentration of 800 to ~900 ng/mL; Talbutal at a concentration of 80 to ~125 ng/mL. Customers were also informed that the presence of Glutethimide in urine at a concentration of ~ 8 to 80 g/mL may lead to false positive results. Customers were instructed to discontinue use and discard all BARB reagent lots M903174 and older following their laboratory's disposal protocol. Customers were informed that negative results due to the differences between the claimed and actual cross reactivity concentrations are not clinically significant, and that per the current Chemistry Information Sheet for this product, the reporting of a positive result by this assay should be confirmed by another generally accepted nonimmunological method; therefore retrospective review of patient results is not required. Customers were requested to share this information with their laboratory staff and retain this recall notification as part of their laboratory Quality System documentation. If customers forwarded any of the affected product listed to another laboratory, they were requested to provide that laboratory a copy of Urgent Recall Notification Letter. Customers were requested to respond to Beckman Coulter within 10 days, electronically if the customer received the notification by email; or manu
Quantity in commerce: 10,145 units
Distribution: Worldwide distribution - US Nationwide distribution and to multiple countries.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1799-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1799-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-24

Product code DIS

K944075Class IICx(tm) Barbiturates(barb) Reagent for Synchron Cx SystBeckman Instruments, Inc. / cleared 1994-12-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)