Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, conta
FDA device recall Z-1496-04 · posted 2004-09-30 · Terminated
Recall details
- Recalling firm
- Fisher Diagnostic, A Company of Fisher Scientific LLC
- Reason for recall
- Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives.
- Action taken
- The firm ceased distribution on 8/24/04 and initiated recall by certified letter dated 9/3/04, which was flagged as 'customer recall notification'. The notice advised of the defective vials and requested users to return response form with the numbers of kits to be returned for replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- GHM
- Quantity affected
- 604 kits
- Distribution
- Product was distributed through the manufacturer''s affiliate distribution company to 228 end users nationwide.
- Date initiated
- 2004-09-03
- Date posted
- 2004-09-30
- Date terminated
- 2005-05-03
- Location
- Middletown, VA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THROMBO SCREEN SICKLE CELL ASSAY SET (K854079) | Pacific Hemostasis | 1985-10-31 |