StrepQuick™

HARDY DIAGNOSTICS · Model Z122 · UDI-DI 00819398028615

510(k) clearances

Adverse events

Recalls

Facilities

Description

StrepQuick™, to aid in the identification of gram positive cocci, performs a PYR, LAP, and Esculin test StrepQuick™ test kit is intended to aid in the identification of gram-positive, catalase-negative cocci based on pyroglutamate aminopeptidase (PYR), leucine aminopeptidase (LAP), and esculin hydrolysis (ESC) activity. This test kit simplifies identification of Enterococcus spp. and group A streptococci (Streptococcus pyogenes) Contains: StrepQuick Test Card (25) 00819398027274 Developer Reagent (1) 00819398028585

Recalls

Date	Firm	Reason
2025-10-23	Becton 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
2016-01-08	BioMerieux SA	Discrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests of the strips linked
2014-10-23	Remel Inc	A reagent within the test may return false negative results.
2014-10-23	Remel Inc	A reagent within the test may return false negative results.
2014-03-17	Remel Inc	A reagent contained within the product may return false negative results.
2014-03-17	Remel Inc	A reagent contained within the product may return false negative results.
2014-03-06	BioMerieux SA	bioMerieux 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
2014-03-06	BioMerieux SA	bioMerieux 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
2014-03-06	BioMerieux SA	bioMerieux 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
2014-03-06	BioMerieux SA	bioMerieux 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 key Read 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.