Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127
FDA Recall Z-0513-04 · Posted 2004-07-20
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Recalling FirmDiamedix Corporation
Recall StatusTerminated
Product CodeLIP
Date Initiated2003-12-09
Date Terminated2008-11-20
Product Quantity8
Reason for Recall
The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results.
Firm Action
A recall notification letter was mailed to each consignee/user account on 12/9/2003 telling them that the recalled lot may give a higher frequency of equivocal/weak positive results. It requests them to discontinue use and to return the product to them. Also they are asked to sign and date the bottom of the recall letter and fax it back to the recalling firm.
Root Cause
Other
Distribution Pattern
Product was distributed to three hospitals/clinics in AZ, CA and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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