The MDA system with MDA Antithrombin III MDA Heparin
FDA device recall Z-0043-05 · posted 2004-10-23 · Terminated
Recall details
- Recalling firm
- bioMerieux
- Reason for recall
- The firm received complaints regarding an observed bias in percent activity between capped and uncapped specimens.
- Action taken
- Consignees were initially notified by letter on June 11, 2004. A follow up letter was sent to consignees, via Fedex on July 9, 2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- JPA
- Distribution
- Nationwide, Australia, Belgium, Brazil, Canada, China, Germany, Italy, Japan, Taiwan, UK
- Date initiated
- 2004-06-11
- Date posted
- 2004-10-23
- Date terminated
- 2005-06-07
- Location
- Durham, NC
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