Recall Z-1069-2007 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Abbott Diagnostic International, Ltd.
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.
| Date | Jul 12, 2007 (initiated Apr 10, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots. |
| Quantity | 3176 kits |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935673 | AXSYM TOTAL B-HCG Abbott Laboratories, Jun 21, 1994 |