Hardy Diagnostics: HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphyloc

Is my product affected?

HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to diagnose infection of guide therapy. Further testing required for susceptibility o

• UPC 00816576020140

Check against the official notice below — it lists the full affected range.

What happened

Hardy Diagnostics is recalling HardyCHROM MRSA chromogenic medium (Catalogue number G307, Lot number 447694) used to detect methicillin-resistant Staphylococcus aureus colonization. The product can produce false positive results because methicillin-susceptible Staphylococcus aureus (MSSA strain ATCC 29213) is not being properly inhibited as intended. The recall affects 3,580 units distributed across multiple U.S. states including Wisconsin, California, Washington, Iowa, Montana, Utah, Arizona, Wyoming, Kansas, Missouri, Oregon, and Texas, as well as U.S. territories and international locations including the British Virgin Islands and Kenya.

The recall could impact laboratory test results for patients whose samples were processed using this lot of medium, potentially leading to incorrect diagnostic findings. The product source does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited. Distribution: U.S. Distribution in the states of WI, CA, WA, IA, MT, UT, AZ, WY, KS, MO, OR, TX, VI, including PR and Guam. OUS: British Virgin Islands, Kenya, Quantity: 3,580 ea (358 kits, pack of 10 in each) Lot/code info: Catalogue no.: G307, Lot number 447694 HDx, UDI # 00816576020140

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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