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ASI Sickle Cell Test
ARLINGTON SCIENTIFIC, INC. · Model NC-200025 · UDI-DI 00816057020003
10
510(k) clearances
19
Adverse events
5
Recalls
7
Facilities
Description
Detection of presence of Hgb-S
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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Get your free API keyRead the docsData 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.