FDA Device Intelligence
Home › HARDY DIAGNOSTICS › AlbiQuick™

AlbiQuick™

HARDY DIAGNOSTICS · Model Z121 · UDI-DI 00819398028608

LIB
10
510(k) clearances
9
Adverse events
13
Recalls
54
Facilities

Description

AlbiQuick™, for Candida albicans differentiation, 5 minute test, 25 tests per kit The new Hardy AlbiQuick™ utilizes two enzyme color reactions to produce an accurate result that’s easy to read out. AlbiQuick is performed on a convenient card with two reaction wells. Only Candida albicans possesses the enzymes that will hydrolyze the PRO and NAG compounds on the card. Incubation time is only five minutes at room temperature! Requires the use of a handheld 366nm ultra violet lamp(see Cat. no. UVL56). The old germ tube method of C. albicans identification requires several hours of incubation and tedious microscopy to produce a result. The AlbiQuick™ eliminates the need for this and other lengthy procedures. A recent study, which compared the above NAG and PRO methods to the traditional germ tube test, showed a sensitivity of 99% and a specificity of 99-100% (the germ tube test showed a sensitivity of 95% and a specificity of 99%; all isolates confirmed by API 20C). Ref: Crist, et al, J. Clin. Microbiol. 34:2616-2618. Accurate, fast, and convenient...that’s AlbiQuick™! Contains: Albiquick Test Cards (25) 00819398027298 Albiquick Reagent A (1) 00816576029051 Developer Reagent (1) 00819398028585

Recalls

DateFirmReason
2025-10-23Becton Dickinson & Co.The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an erro
2016-01-08BioMerieux SADiscrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests of the strips linked
2014-10-23Remel IncA reagent within the test may return false negative results.
2014-10-23Remel IncA reagent within the test may return false negative results.
2014-03-17Remel IncA reagent contained within the product may return false negative results.
2014-03-17Remel IncA reagent contained within the product may return false negative results.
2014-03-06BioMerieux SAbioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Ra
2014-03-06BioMerieux SAbioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Ra
2014-03-06BioMerieux SAbioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Ra
2014-03-06BioMerieux SAbioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Ra

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.