FDA Medical Device Recalls (openFDA)
Abbott Diagnostic International, Ltd.: Total B-hCG Speciment Diluent is composed of 1 bottle of Total B-hCG Specimen Diluent containing animal serum.
- Recall number
- Z-1070-2007
- Recalling firm
- Abbott Diagnostic International, Ltd.
- Product
- Total B-hCG Speciment Diluent is composed of 1 bottle of Total B-hCG Specimen Diluent containing animal serum.
- Status
- Terminated
- Initiated
- 2007-04-10
- Posted
- 2007-07-12
- Terminated
- 2012-02-14
- Reason
- 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.
- Root cause
- Other
- Action
- The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots.
- Quantity
- 1853
- Distribution
- 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.
- Lot, serial or model codes
- 45033Q100, 46212Q100,46776Q100, 47117Q100, 47619Q100.
- 510(k) numbers
- ["K935673"]
- PMA numbers
- not on file
- Product code
- JHI
- Firm FEI
- 2623532
- Firm city
- Barceloneta
- Firm state
- PR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28