Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila
Lot Codes / Batch Numbers
46329Q101, 47118Q101, 48063Q101, 48065Q101, 49341Q101, 49559Q101
Products Sold
46329Q101, 47118Q101, 48063Q101, 48065Q101, 49341Q101, 49559Q101
Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila is recalling AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles 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