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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations.
Brand
Fisher Diagnostic, A Company of Fisher Scientific LLC
Lot Codes / Batch Numbers
Lot 250-403 and 250-404, EXP 4/30/2006
Products Sold
Lot 250-403 and 250-404, EXP 4/30/2006
Fisher Diagnostic, A Company of Fisher Scientific LLC is recalling Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog due to Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026