Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969
FDA device recall Z-0054-05 · posted 2004-10-28 · Terminated
Recall details
- Recalling firm
- bioMerieux
- Reason for recall
- Complaints were received from the field regarding prolonged clot times, high control values and erratic results.
- Action taken
- Consignees were notified by letter on 8/20/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJA
- Quantity affected
- 2406 units
- Distribution
- Nationwide, Australia, Brazil, Canada, China, Japan, Laos, Philippines, UK
- Date initiated
- 2004-08-20
- Date posted
- 2004-10-28
- Date terminated
- 2005-06-09
- Location
- Durham, NC
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