Home › Device types › GHM
Test, Sickle Cell
FDA product code GHM · Class 2 · Hematology
19
Registered devices
19
Adverse events
5
Recalls
18
510(k) clearances
Devices with this code
SICKLEDEX — STRECK, INC.Sickle-Heme — GREAT LAKES DIAGNOSTICS, INC.Sickle-Chex — STRECK, INC.ASI Sickle Cell Test — ARLINGTON SCIENTIFIC, INC.Thermo Scientific Pacific Hemostasis® — Fisher DiagnosticsASI Sickle Cell Test — ARLINGTON SCIENTIFIC, INC.Sickle-Heme — GREAT LAKES DIAGNOSTICS, INC.Sickle-Heme — GREAT LAKES DIAGNOSTICS, INC.Sickle-Heme — GREAT LAKES DIAGNOSTICS, INC.ASI Sickle Cell Test — ARLINGTON SCIENTIFIC, INC.Sickle-Chex — STRECK, INC.SICKLEDEX — STRECK, INC.SICKLEDEX — STRECK, INC.ASI Sickle Cell Test — ARLINGTON SCIENTIFIC, INC.Dade® Sickle-Sol Test — Siemens Healthcare Diagnostics Products GmbHSickle-Heme — GREAT LAKES DIAGNOSTICS, INC.Dade® Sickle-Sol Test — Siemens Healthcare Diagnostics Products GmbHThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsThermo Scientific Pacific Hemostasis® — Fisher Diagnostics
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-02-23 | MichClone Associates, Inc. | Michclone Associate's has received two complaints concerning the powder vial included in the 100 test kit observed producing pressure while sealed. When the p |
| 2012-02-23 | MichClone Associates, Inc. | 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 pre |
| 2012-02-23 | MichClone Associates, Inc. | Two complaints received concerning the powder vial included in the 100 test kit observed producing pressure while sealed. When the powders are opened, the pre |
| 2005-12-16 | Chembio Diagnostic System Inc | 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 n |
| 2004-09-03 | Fisher Diagnostic, A Company of Fisher Scientific LLC | Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives. |
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