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HardyCHROM™

HARDY DIAGNOSTICS · Model J28 · UDI-DI 00816576026845

JSO

510(k) clearances

764

Adverse events (1 deaths)

Recalls

Facilities

Description

HardyCHROM™ CRE/ HardyCHROM™ ESBL, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ CRE is a selective and differential chromogenic medium intended for the qualitative and presumptive detection from stool, rectal swabs, and related specimens of Escherichia coli that are non-susceptible to carbapenems as pink colonies and KES that are non-susceptible to carbapenems as blue colonies. HardyCHROM™ ESBL s a selective and differential chromogenic medium that is intended for the qualitative and presumptive detection from stool specimens of 1) Enterobacterales that are potentially non-susceptible to ceftazidime and cefpodoxime; and 2) Extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae , and Klebsiella oxytoca.

Recalls

Date	Firm	Reason
2025-05-06	Hardy Diagnostics	Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
2023-05-31	Remel, Inc	The test medium may not perform as intended.
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed

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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.