Date Initiated by Firm | February 26, 2013 |
Date Posted | April 18, 2013 |
Recall Status1 |
Terminated 3 on August 29, 2013 |
Recall Number | Z-1148-2013 |
Recall Event ID |
64790 |
510(K)Number | K042272 |
Product Classification |
System, test, infectious mononucleosis - Product Code KTN
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Product | IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201
The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis. |
Code Information |
The affected control lot number is 11030386. Lot/Unit Codes: MON1040008 & MON1040016. |
Recalling Firm/ Manufacturer |
Alere San Diego, Inc. 9975 Summers Ridge Rd San Diego CA 92121-2997
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For Additional Information Contact | 858-805-2000 Ext. 3015 |
Manufacturer Reason for Recall | Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results. |
FDA Determined Cause 2 | Material/Component Contamination |
Action | Alere sent an Urgent Medical Device Recall letter dated February 26, 2013, to all affected customers. The letter informs the customers of the problems identified and the actions to be taken. Customers with unused product remaining are instructed to immediately discard it. Investigations of customer complaints indicate that the positive control included with this lot may produce false negative results. Customers are instructed to return the attached Verification form. Customers that have consumed all product are instructed to indicate zero under "Quantity Discarded" and complete and fax back the form. Replacement product will be provided for any unused portion of the affected lot based on completion and return of the attached Verification Form. Customers with any questions are instructed to contact Alere Technical Services at (866) 216-0094 or by email at later.flow.support@alere.com.
For questions regarding this recall call 858-805-2000, ext 3015. |
Quantity in Commerce | 78 kits |
Distribution | Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = KTN
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