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.
FDA Recall Z-0784-05 · Posted 2005-04-28
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Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeLIP
Date Initiated2005-03-16
Date Terminated2006-07-22
Product Quantity14 kits
Reason for Recall
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
MA, CA, TX, KS, NY, FL
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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