AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B-hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF 7A59-21. 100 Tests. For In Vitro Diagnostic Use.
This recall has been terminated (originally issued July 12, 2007).
- Recall Initiated
- April 10, 2007
- Posted
- July 12, 2007
- Terminated
- February 14, 2012
- Recall Number
- Z-1067-2007
- Quantity
- 11530 kits
- Firm Location
- Barceloneta, PR
- Official Source
- View on FDA website ↗
Reason for Recall
An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted then the background effect is magnified potentially yelding false positive results for pregnancy and or Dilution Inaccuracy.
Distribution
Worldwide, including USA, PR, USVI, CANADA, MEXICO, GUATEMALA, COSTA RICA, COLOMBIA, ECUADOR, PERU, CHILE, URUGUAY, ARGENTINA, BRAZIL, DOMINICAN REPUBLIC, EL SALVADOR, GERMANY, JAPAN, SINGAPORE, HONG KONG, TAIWAN, THAILAND, SOUTH KOREA, AUSTRALIA, NEW ZEALAND, HONDURAS, TRINIDAD & TOBAGO, GRENADA, ST. VINCENT, ST. LUCIA, ANTIGUA, BARBADOS, CURACAO, BRITISH VIRGIN ISLANDS, BAHAMAS, PANAMA, and CAYMAN ISLANDS.
Lot / Code Info
46329Q101, 47118Q101, 48063Q101, 48065Q101, 49341Q101, 49559Q101
Root Cause
Other
Action Taken
The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots.