IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti B-hCG Alkaline Phosphatase Conjungate, one bottle of 4-Methylumbelliferyl Phosphate and one bottle of Specimen Diluent.
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-1069-2007
- Quantity
- 3176 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
46810Q100, 49118Q100, 49555Q100
Root Cause
Other
Action Taken
The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots.