Hardy Diagnostics: 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.

Agency Publication Date: July 29, 2015

Affected Products

Product: Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical samples.

Lot number: 15096 and 15107

Lot Numbers:

number

Product: Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples.

Lot number: 15055, 15083, and 15091

Lot Numbers:

number

Product: Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.

Lot number: 15092, 15101, 15113 Cat no. G259

Lot Numbers:

number

Product: Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.

Lot number: 15075. 15096, 15107, 15121, 15134, and 15154 Cat no. G103

Lot Numbers:

number

Product: Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).

Lot number: 15105 Cat no. G107

Lot Numbers:

number

Product: Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting

Lot number: 15070 Cat no. R98 Lot number: 14193, 14232, 14251, 14272, and 14329 Cat no.: R72

Lot Numbers:

number

Product: Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting.

Lot number: 15021, 15043, 15072, 15126, 15152 Cat no. K103

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71602

Status: Resolved

Manufacturer: Hardy Diagnostics

Manufactured In: United States

Units Affected: 7 products (730 (73pk/10); 520 (26pk/20); 650 (65 pk/10); 5,940 (5940 pk/10); 100 (10 pk/10); 100 each and 1,860 each (186 pk/10); 900 each (90 pk/10))

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot number: 15096 and 15107

Lot Numbers:

number

Lot number: 15055, 15083, and 15091

Lot Numbers:

number

Lot number: 15092, 15101, 15113 Cat no. G259

Lot Numbers:

number

Lot number: 15075. 15096, 15107, 15121, 15134, and 15154 Cat no. G103

Lot Numbers:

number

Lot number: 15105 Cat no. G107

Lot Numbers:

number

Lot number: 15070 Cat no. R98 Lot number: 14193, 14232, 14251, 14272, and 14329 Cat no.: R72

Lot Numbers:

number

Lot number: 15021, 15043, 15072, 15126, 15152 Cat no. K103

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71602

Status: Resolved

Manufacturer: Hardy Diagnostics

Manufactured In: United States

Units Affected: 7 products (730 (73pk/10); 520 (26pk/20); 650 (65 pk/10); 5,940 (5940 pk/10); 100 (10 pk/10); 100 each and 1,860 each (186 pk/10); 900 each (90 pk/10))