CLASS II Device recall · Reported 17 Jun 2020 · FDA Enforcement Report

HardyCHROM MRSA recalled by Hardy Diagnostics

Hardy Diagnostics is recalling HardyCHROM MRSA, distributed in 13 states. The recall was initiated on 14 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalogue no.: G307, Lot number 447694 HDx, UDI # 00816576020140

Quantity recalled3,580 ea (358 kits, pack of 10 in each)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2298-2020
FDA event ID: 85412
Recalling firm: Hardy Diagnostics, Santa Maria, CA
Classification: Class II
Status: Terminated
Recall initiated: 14 Nov 2019
FDA classified: 8 Jun 2020
Reported: 17 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

14 Nov 2019	Recall initiated by company
8 Jun 2020	Classified by FDA	+207 days
17 Jun 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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 or typing. Container Type: 15 x 100mm monoplate Packaged: 10 plates/sleeve STORAGE: 2-8 degree C on receipt, LIGHT SENSITIVE IVD UDI: (01)08165760201400 (10)447694 (17)191206

Where it was distributed

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,

Arizona California Iowa Kansas Missouri Montana Oregon Puerto Rico Texas Utah Washington Wisconsin Wyoming

Questions about this recall

Is HardyCHROM MRSA recalled?

Yes. Hardy Diagnostics recalled HardyCHROM MRSA on 14 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-2298-2020.

Why was it recalled?

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

Which lots are affected?

Catalogue no.: G307, Lot number 447694 HDx, UDI # 00816576020140

Where was it sold?

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,

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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