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.
- Company
- Diasorin Inc.
- Recall Initiated
- March 16, 2005
- Posted
- April 28, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0784-05
- Quantity
- 14 kits
- Firm Location
- Stillwater, MN
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.
Distribution
MA, CA, TX, KS, NY, FL
Lot / Code Info
lot # 041207T expiration date 9-30-2005
Root Cause
Other
Action Taken
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.
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