Test, Sickle Cell
Hematology · 21 CFR 864.7825
Recent MDR events
19 adverse event reports on file
- SICKLEDEX TUBE TEST FOR HEMOGLOBIN SApr 3, 2006MalfunctionOrtho-clinical Diagnostics, Inc.2250051-2006-50140
- Unnamed deviceApr 3, 2006Malfunction2250051-2006-00140
- SICKLEDEX TUBE TEST OF HEMOGLOBIN SOct 3, 2003MalfunctionOrtho-clinical Diagnostics, Inc.2250051-2003-01134
- *Oct 3, 2003Malfunction*2250051-2003-00534
- SICKLEDEX TUBE TEST OF HEMOGLOBIN SJul 23, 2003MalfunctionOrtho-clinical Diagnostics, Inc.2250051-2003-00919
- *Jul 23, 2003Malfunction*2250051-2003-00319
- SICKLEDEX TUBE TEST OF HEMOGLOBIN SJul 23, 2003MalfunctionOrtho-clinical Diagnostics, Inc.2250051-2003-00918
- *Jul 23, 2003Malfunction*2250051-2003-00318
- SICKLEDEX TUBE TEST HEMOGLOBIN SJul 23, 2003MalfunctionOrtho-clinical Diagnostics, Inc.2250051-2003-00917
- *Jul 23, 2003Malfunction*2250051-2003-00317
Event type breakdown
Recalls
5 recall events for this product code
- MichClone Associates, Inc.TerminatedMay 9, 2012
Sickle Heme, Hemoglobin S Solubility For Qualitative Determination of Hemoglobin S Test; ,100 Test Kit Product, No MCA 100, Contents: Two bottles of Sickle Cell
Michclone Associate's has received two complaints concerning the powder vial included in the 100 test kit observed producing pressure while sealed. When the powders are opened, the pressure from within the vial releases a small amount of powder into the air. This powder. if released near the face and inhaled can cause minor irritation resulting in sneezing and nasal congestion. Investigation f
Z-1501-2012 · View FDA record ↗ - MichClone Associates, Inc.TerminatedMay 9, 2012
BioTron Sickle Cell Reagent Set, Screening test for the Presence of Hemoglobin S 2 x 100 ml Sickle Cell Buffer, 2 vials sickle Cell Reagent, Size 100 tests, Sto
Two complaints received concerning the powder vial included in the 100 test kit observed producing pressure while sealed. When the powders are opened, the pressure from within the vial releases a small amount of powder into the air. This powder. if released near the face and inhaled can cause minor irritation resulting in sneezing and nasal congestion. Investigation found no affect on the perf
Z-1502-2012 · View FDA record ↗ - MichClone Associates, Inc.TerminatedMay 9, 2012
Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin S Two bottles Sickle Cell Solubility Buffer, 100 m
Two complaints concerning the powder vial included in the 100 test kit has been observed producing pressure while sealed. When the powders are opened, the pressure from within the vial releases a small amount of powder into the air. This powder. if released near the face and inhaled can cause minor irritation resulting in sneezing and nasal congestion. Investigation found no affect on the perf
Z-1503-2012 · View FDA record ↗ - Chembio Diagnostic System IncTerminatedFeb 4, 2006
Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC U
Firm received one report of a false negative with the positive control. Internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations.
Z-0470-06 · View FDA record ↗ - Fisher Diagnostic, A Company of Fisher Scientific LLCTerminatedSep 30, 2004
Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations.
Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives.
Z-1496-04 · View FDA record ↗
Registered firms
9 firms currently registered for this product code
Arlington Scientific, Inc.
SPRINGVILLE, UT, US
Sa Scientific, Ltd
SAN ANTONIO, TX, US
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Fisher Diagnostics
MIDDLETOWN, VA, US
Michclone Associates, Inc.
Troy, MI, US
Streck Llc
La Vista, NE, US
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
510(k) clearances
18 clearances for this product code
- Streck Laboratories, Inc.Dec 30, 2002
K023656 · SICKLE-CHEX SOLUBILITY KIT
- Streck Laboratories, Inc.Nov 6, 2001
K013316 · SICKLE-CHEX
- Sa Scientific, Inc.Jul 1, 1996
K960947 · SAS SICKLE CELL TEST
- Isolab, Inc.Oct 9, 1991
K911981 · HEMOCARD HEMOGLOBIN S
- Isolab, Inc.Apr 15, 1991
K910430 · HEMOCARD-AS
- Pacific HemostasisJul 31, 1987
K872217 · THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT
- Michclone Associates, Inc.Apr 11, 1986
K860812 · SICKLE CELL REAGENT SET
- Sterling Diagnostics, Inc.Feb 24, 1986
K860420 · SICKLE CELL REAGENT SET