AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti
FDA device recall Z-1067-2007 · posted 2007-07-12 · Terminated
Recall details
- Recalling firm
- Abbott Diagnostic International, Ltd.
- 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.
- Action taken
- The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots.
- Root cause
- Other
- Status
- Terminated
- Product code
- JHI
- Quantity affected
- 11530 kits
- 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
- Date initiated
- 2007-04-10
- Date posted
- 2007-07-12
- Date terminated
- 2012-02-14
- Location
- Barceloneta, PR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXSYM TOTAL B-HCG (K935673) | Abbott Laboratories | 1994-06-21 |