Abbott Laboratories MPG ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Abbott Laboratories, Abbott Park, IL 60064 USA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Abbott Laboratories, Abbott Park, IL 60064 USA
Brand
Abbott Laboratories MPG
Lot Codes / Batch Numbers
list number 7B34-16, lot numbers 16006M200 and 19199M300
Products Sold
list number 7B34-16, lot numbers 16006M200 and 19199M300
Abbott Laboratories MPG is recalling ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains due to False Positive results may be obtained with the identified lots of list 7B34-16 when using a negative patient sample or a negative control.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
False Positive results may be obtained with the identified lots of list 7B34-16 when using a negative patient sample or a negative control.
Recommended Action
Per FDA guidance
Abbott notified their affiliates in all four countries via e-mail on 3/16/05. Each Abbott international country organization is responsible for translating the customer letter, contacting customers and determining the method of effectiveness checks based on their country requirements. The recall letters inform the accounts of the false positve results, and were requested to destroy any remaining inventory of 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 noticePage updated: Jan 10, 2026