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U.S. Department of Health and Human Services

Class 2 Device Recall Calloway LabsMultiDrug 9 Panel Assay

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  Class 2 Device Recall Calloway LabsMultiDrug 9 Panel Assay see related information
Date Initiated by Firm June 10, 2011
Date Posted July 27, 2011
Recall Status1 Terminated 3 on April 04, 2012
Recall Number Z-2881-2011
Recall Event ID 59101
510(K)Number K061718  
Product Classification Enzyme Immunoassay, Amphetamine - Product Code DKZ
Product Calloway LabsMulti-Drug 9 Panel Assay

A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug metabolites in human urine.

Code Information Model/Catalog Number: DOA-197-201-19-0NW506A,   Lot/Unit Codes: DOA1040725, DOA1040758, DOA1040784, DOA1040669 & DOA1040689
Recalling Firm/
Manufacturer		 Alere San Diego
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact
858-455-4808 Ext. 3015
Manufacturer Reason
for Recall		 Alere is initiating a voluntary recall on the listed lots of MULTI-DRUG 9 PANEL INTEGRATED CUP manufactured by Alere for sole use by Calloway Labs due to a mistake that occurred while processing the order, these products were incorrectly labeled as CLIA Waived, when in fact the devices are classified as Moderately Complex. Therefore these devices are misbranded.
FDA Determined
Cause 2		 Vendor change control
Action Alere San Diego sent an "Urgent Medical Device Recall" letter dated June 9, 2011 to all affected customers. The letter included: products affected, reason for recall and instructed them to return all affected product. An acknowledgement form was also included for the customer to return to Alere. For questions contact Technical Services at 888.246.7483, option 2 or by e-mail at InnovaconComplaints@alere.com.
Quantity in Commerce 2400 kits (60,000 devices)
Distribution (USA) Nationwide Distribution including the states of MO and MA.
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 = DKZ and Original Applicant = INNOVACON, INC.
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