Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila
Lot Codes / Batch Numbers
46810Q100, 49118Q100, 49555Q100
Products Sold
46810Q100, 49118Q100, 49555Q100
Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila is recalling IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026