Recall Z-2463-2015— Hardy Diagnostics
Class II · Terminated
Class II FDA medical device recall by Hardy Diagnostics, initiated 2015-07-09, terminated 2015-11-10. It names one FDA 510(k) clearance: K102922. Product: HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com. Reason: 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..
- Recalling firm
- Hardy Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-09
- Terminated
- 2015-11-10
- Firm location
- Santa Maria, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.