Diasorin Inc. Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2.
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
lot # 041207T expiration date 9-30-2005
Products Sold
lot # 041207T expiration date 9-30-2005
Diasorin Inc. is recalling Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Nort due to Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be dilute. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter.
Recommended Action
Per FDA guidance
Customers were contacted via telephone, informed of the incorrect package insert, asked to destroy any incorrect inserts and a correct insert was faxed to customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, KS, MA, NY, TX
Page updated: Jan 10, 2026