Recalling Firm / Manufacturer

Abbott Diagnostic International, Ltd

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.

Code Information

46329Q101, 47118Q101, 48063Q101, 48065Q101, 49341Q101, 49559Q101

Reason of 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.

Date Recall Initiated

April 10, 2007

Action

The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots. Firm Initiated recall is ongoing.

Contact

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.