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Terminated

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

FDA Recall Z-1392-05 · Posted 2005-08-24

Recalling FirmAbbott Laboratories MPG
Recall StatusTerminated
Product CodeJHI
Date Initiated2005-03-16
Date Terminated2006-05-25
Product Quantity7607 kits

Reason for Recall

False Positive results may be obtained with the identified lots of list 7B34-16 when using a negative patient sample or a negative control.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Canada, Germany, Hong Kong and Australia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K965116ABBOTT TESTPACK PLUS HCG COMBO WITH OBCAbbott Laboratories · 1997-02-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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