SICKLEDEX

STRECK, INC. · Model 217657 · UDI-DI 00844509002048

510(k) clearances

Adverse events

Recalls

Facilities

Description

A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human blood or sickle cell control material. Contains 100 tests.

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 powders are opened, t
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 pressure from within th
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 pressure from within th
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 negative interpretati
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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.