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Terminated

Total B-hCG Speciment Diluent is composed of 1 bottle of Total B-hCG Specimen Diluent containing animal serum.

FDA Recall Z-1070-2007 · Posted 2007-07-12

Recalling FirmAbbott Diagnostic International, Ltd.
Recall StatusTerminated
Product CodeJHI
Date Initiated2007-04-10
Date Terminated2012-02-14
Product Quantity1853

Reason for 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.

Firm Action

The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, PR, USVI, CANADA, MEXICO, GUATEMALA, COSTA RICA, COLOMBIA, ECUADOR, PERU, CHILE, URUGUAY, ARGENTINA, BRAZIL, DOMINICAN REPUBLIC, EL SALVADOR, GERMANY, JAPAN, SINGAPORE, HONG KONG, TAIWAN, THAILAND, SOUTH KOREA, AUSTRALIA, NEW ZEALAND, HONDURAS, TRINIDAD & TOBAGO, GRENADA, ST. VINCENT, ST. LUCIA, ANTIGUA, BARBADOS, CURACAO, BRITISH VIRGIN ISLANDS, BAHAMAS, PANAMA, and CAYMAN ISLANDS.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K935673AXSYM TOTAL B-HCGAbbott Laboratories · 1994-06-21

Official Source

View FDA Recall →

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

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