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
Hazard
The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results.
What You Should Do
Remedy
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.
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Products
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 3
- Brand
- Diamedix Corporation
- UPC
- Lot Number 71303, expiration date June 2004
Units Affected
8