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Terminated

ABBOTT TestPack +Plus hCG Combo, list 3A60-16; the kit contains 20 reaction discs, anti-beta hCG (Goat) and anti-alpha hCG (Mouse, Monoclonal) coated, and 20 transfer pipettes; Abbott Laboratories, Abbott Park, IL 60064 USA

FDA Recall Z-1399-05 · Posted 2005-08-24

Recalling FirmAbbott Laboratories MPG
Recall StatusTerminated
Product CodeJHI
Date Initiated2005-08-07
Date Terminated2006-03-27
Product Quantity3049 kits

Reason for Recall

False Positive results may be obtained with the identified lot of list 3A60-16 when using a negative patient sample or a negative control.

Firm Action

Abbott notified their affiliates in all eight countries via e-mail on 8/7/05. 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 positive results, and were requested to return any remaining inventory of the affected lots to Abbott in Germany.

Root Cause

Other

Distribution Pattern

This product is not distributed in the U.S. It was distributed internationally to Canada, Germany, Honduras, Nicaragua, the Bahamas, the Philippines (via Singapore), New Zealand, and Uruguay

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K903219ABBOTT TESTPACK PLUS TM HCG-COMBOAbbott Laboratories · 1990-09-25

Official Source

View FDA Recall →

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

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