FDA Medical Device Recalls (openFDA)
Fisher Diagnostic, A Company of Fisher Scientific LLC: Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations.
- Recall number
- Z-1496-04
- Recalling firm
- Fisher Diagnostic, A Company of Fisher Scientific LLC
- Product
- Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations.
- Status
- Terminated
- Initiated
- 2004-09-03
- Posted
- 2004-09-30
- Terminated
- 2005-05-03
- Reason
- Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives.
- Root cause
- Other
- Action
- 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.
- Quantity
- 604 kits
- Distribution
- Product was distributed through the manufacturer''s affiliate distribution company to 228 end users nationwide.
- Lot, serial or model codes
- Lot 250-403 and 250-404, EXP 4/30/2006
- 510(k) numbers
- ["K854079"]
- PMA numbers
- not on file
- Product code
- GHM
- Firm FEI
- 1181121
- Firm city
- Middletown
- Firm state
- VA
- 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