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GlabrataQuick™

HARDY DIAGNOSTICS · Model Z298 · UDI-DI 00819398028691

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

Description

GlabrataQuick™, for the identification of Candida glabrata, 24 tests GlabrataQuick™, contains two 96 well trays and 24 Inoculation Buffer tubes with 1ml fill to complete a total of 24 tests. GlabrataQuick™ will accurately identify Candida glabrata within one to two hours. It tests for three carbohydrates for greater accuracy; trehalose, sucrose, and maltose. Easy and distinct color read-out. Carbohydrates turn from blue to yellow. A great test to use in conjunction with the HardyCHROM Candida plate (cat. no. G301). Contains: GlabrataQuick Reaction Strips (24) 00819398027595 GlabrataQuick Inoculation Buffer, 1ml (24) 00819398028684

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

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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.