FDAClass IIJuly 29, 2015

HardyCHROM VRE Agar-RSR Cat no: GA333 recall

HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8…

Why was HardyCHROM VRE Agar-RSR Cat no: GA333 recalled?

Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Cat No.: G333 Lot No.: H15055

Product
HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8…
Recalling firm
Hardy Diagnostics
Quantity
1,500
Distribution
Distributed to one U.S. customer in SC.
Recall date
July 29, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls