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HARDY DIAGNOSTICS · Model 4001NF · UDI-DI 00816576023707

KZI JSH JSI

510(k) clearances

3,143

Adverse events

Recalls

Facilities

Description

Urine Quad Plate, 15x100, Quadplate, 10/pk Used for the isolation and differentiation of microorganisms found in urine specimens. Quad 1: EMB, Levine Quad 2: Modified XLD Agar Quad 3: Simmons Citrate Quad 4: TSA with 5% Sheep Blood

Recalls

Date	Firm	Reason
2009-02-19	Becton Dickinson & Co.	In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms.
2004-09-27	Remel, Inc.	The product does not perform as intended with some quality control organisms (Haemophilus influenzae)

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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.