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U.S. Department of Health and Human Services

Class 2 Device Recall SYNCHRON Systems Barbiturates Reagent (BARB reagent)

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  Class 2 Device Recall SYNCHRON Systems Barbiturates Reagent (BARB reagent) see related information
Date Initiated by Firm June 12, 2019
Create Date April 24, 2020
Recall Status1 Terminated 3 on December 11, 2020
Recall Number Z-1799-2020
Recall Event ID 85140
510(K)Number K944075  
Product Classification Enzyme immunoassay, barbiturate - Product Code DIS
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact David Davis
714-961-5321
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DIS and Original Applicant = BECKMAN INSTRUMENTS, INC.
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