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
This recall has been terminated (originally issued July 20, 2004).
- Company
- Diamedix Corporation
- Recall Initiated
- December 9, 2003
- Posted
- July 20, 2004
- Terminated
- November 20, 2008
- Recall Number
- Z-0513-04
- Quantity
- 8
- Firm Location
- Miami, FL
- Official Source
- View on FDA website ↗
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.
Distribution
Product was distributed to three hospitals/clinics in AZ, CA and TX.
Lot / Code Info
Lot Number 71303, expiration date June 2004
Root Cause
Other
Action Taken
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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