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U.S. Department of Health and Human Services

Class 3 Device Recall ORASURE Barbiturates Intercept MicroPlate EIA

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  Class 3 Device Recall ORASURE Barbiturates Intercept MicroPlate EIA see related information
Date Initiated by Firm November 10, 2016
Date Posted December 08, 2016
Recall Status1 Terminated 3 on April 17, 2017
Recall Number Z-0722-2017
Recall Event ID 75681
510(K)Number K001976  
Product Classification Enzyme immunoassay, barbiturate - Product Code DIS
Product Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate)

Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.
Code Information Lot # 6654085
Recalling Firm/
Manufacturer		 OraSure Technologies, Inc.
1745 Eaton Ave
Bethlehem PA 18018-1769
For Additional Information Contact Jose L. Rosado
610-882-1820 Ext. 1657
Manufacturer Reason
for Recall		 Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Due to the small number of customers that were affected by the recall, OraSure notified customers on November 10, 2016, via telephone with a follow-up email. Customers were asked to quarantine the units on hand and they will schedule a pickup by Fed EX to retrieve the affected units. For further questions, please call (610) 882-1820, ext. 1657
Quantity in Commerce 4 kits
Distribution Distributed to KS, and VA
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 = ORASURE TECHNOLOGIES, INC.
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