IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) i

FDA device recall Z-1148-2013 · posted 2013-04-18 · Terminated

Recall details

Recalling firm

Alere San Diego, Inc.

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.

Action taken

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.

Root cause

Material/Component Contamination

Status

Terminated

Product code

KTN

Quantity affected

78 kits

Distribution

Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia

Date initiated

2013-02-26

Date posted

2013-04-18

Date terminated

2013-08-29

Location

San Diego, CA

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