Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 17, 2020
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
False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Hardy Diagnostics recalled HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium f… - a moderate-severity action.
HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium f… was recalled by Hardy Diagnostics in June 17, 2020. Reason: False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) br…. Check the official notice for the remedy. Verify recall #Z-2298-2020 with the FDA Devices before acting.
The recall
Hardy Diagnostics issued this moderate-severity FDA Devices recall-False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) br….
- Moderate
- severity level
- Class II
- classification
- June 17, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2298-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2298-2020) was formally reported on June 17, 2020, with the manufacturer initiating the action on November 14, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Hardy Diagnostics is listed as the recalling firm, operating out of Santa Maria, CA. Federal records list the affected scope as 3,580 ea (358 kits, pack of 10 in each).
The documented reason for this recall is: False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited. Distribution data in the federal record shows the product reached: 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,. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3,580 ea (358 kits, pack of 10 in each)
Related Recalls
6
0 from same agency
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2298-2020 |
| Date reported | June 17, 2020 |
| Date initiated | November 14, 2019 |
| Recalling firm | Hardy Diagnostics |
| Firm location | Santa Maria, CA |
| Affected scope | 3,580 ea (358 kits, pack of 10 in each) |
| 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, |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2298-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hardy Diagnostics. Units affected: 3,580 ea (358 kits, pack of 10 in each).
Why was this product recalled? ▼
False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2020. Severity: Moderate. Recall number: Z-2298-2020.
Where was the recalled product distributed? ▼
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,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2298-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported June 17, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.