Z-1496-04

Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number...

Name: Z-1496-04 Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number...
Creator: Fisher Diagnostic, A Company of Fisher Scientific LLC
Published: 2004-09-03
License: https://open.fda.gov/license/

Fisher Diagnostics / initiated 2004-09-03 / Terminated

FDA source

Fisher Diagnostic, A Company of Fisher Scientific LLC began a recall of Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations on 2004-09-03. The reason FDA records is "Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1496-04
Status: Terminated
Initiated: 2004-09-03
Posted: 2004-09-30
Terminated: 2005-05-03
Recalling firm: Fisher Diagnostics
Product: Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations.
Product code: GHM Test, Sickle Cell
Reason for recall: Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives.
FDA 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 in commerce: 604 kits
Distribution: Product was distributed through the manufacturer''s affiliate distribution company to 228 end users nationwide.
Product codes and lots: Lot 250-403 and 250-404, EXP 4/30/2006

Product code GHM

K854079Class IIThrombo Screen Sickle Cell Assay SetPacific Hemostasis / cleared 1985-10-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)