Recalls for Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.

The test medium may not perform as intended.

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.

Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.

Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.

Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.

Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.

Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.

Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.

Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.

Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.

Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.

Organism strains may fail to consistently produce confluent growth

Organism strains may fail to consistently produce confluent growth

The product failed to prevent growth of methicillin-sensitive Staphylococcus aureus (MSSA)

CHROMagar Products are labeled incorrectly. Label currently states that the product is for IVD use, when it should state that the product is intended For Research Use, Not for use in diagnostic procedures.

CHROMagar Products are labeled incorrectly. Label currently states that the product is for IVD use, when it should state that the product is intended For Research Use, Not for use in diagnostic procedures.

Discrepancies between the product package label and technical insert are conflicting and may be misleading to user. The technical insert included the statement for In Vitro Diagnostic Use. The product insert should have indicated for Research Use Only instead of for In Vitro Diagnostic Use.

Discrepancies between the product package label and technical insert are conflicting and may be misleading to user. The technical insert included the statement for In Vitro Diagnostic Use. The product insert should have indicated for Research Use Only instead of for In Vitro Diagnostic Use.

Marketed a regulated product without a 510(k).

Plates manufactured without vancomycin. Possibility for false resistant results.

This recall is being conducted due to the performance failure nearing the end of the product shelf life.

Sheep Blood products may be contaminated with a Brucella species (B. ovis).

Sheep Blood products may be contaminated with a Brucella species (B. ovis).

Sheep Blood products may be contaminated with a Brucella species (B. ovis).

Sheep Blood products may be contaminated with a Brucella species (B. ovis).

Sheep Blood products may be contaminated with a Brucella species (B. ovis).

Sheep Blood products may be contaminated with a Brucella species (B. ovis).

Sheep Blood products may be contaminated with a Brucella species (B. ovis).

Sheep Blood products may be contaminated with a Brucella species (B. ovis).

Sheep Blood products may be contaminated with a Brucella species (B. ovis).

Sheep Blood products may be contaminated with a Brucella species (B. ovis).

Sheep Blood products may be contaminated with a Brucella species (B. ovis).

Listeria monocytogenes contamination of non-sterile plated media

Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.

HighPuragar was mislabeled and inadvertently sold as Noble Agar.

When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.

When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.

The media allows growth of E. faecalis ATCC 29212 with blackening of the media.

Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.

Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.