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U.S. Department of Health and Human Services

Class 3 Device Recall Cannabinoids Intercept Micro Plate EIA

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 Class 3 Device Recall Cannabinoids Intercept Micro Plate EIAsee related information
Date Initiated by FirmSeptember 08, 2008
Date PostedDecember 18, 2008
Recall Status1 Terminated 3 on December 18, 2008
Recall NumberZ-0481-2009
Recall Event ID 49562
510(K)NumberK002375 
Product Classification Cannabinoid test system. - Product Code LDJ
ProductCannabinoids Intercept Micro Plate EIA 100 plate kit
Code Information Product number 11181C. Lot number 6609532 exp 12/2008
FEI Number 2528909
Recalling Firm/
Manufacturer		 OraSure Technologies, Inc.
1745 Eaton Ave
Bethlehem PA 18018-1769
For Additional Information ContactJackie Ferro
610-882-1820
Manufacturer Reason
for Recall		Readings, high: intermittent high absorbance readings. For further information, please contact the firm at 610-882-1820.
FDA Determined
Cause 2		Other
ActionOn 9/8/08, the recalling firm telephoned the customer to inform them of the problem. As a follow up to the telephone call, the recalling firm issued a recall letter dated 9/11/08 to the customer.
Quantity in Commerce1 kit
DistributionThe product was shipped to one customer in New York.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LDJ
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