FDAClass IINovember 24, 2021

API 50 CH recall

API 50 CH, Model 50300

Why was API 50 CH recalled?

There is potential to provide an incorrect organism identification.

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?

Model 50300, Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230

Product
API 50 CH, Model 50300
Recalling firm
bioMerieux, Inc.
Quantity
1382 kits
Distribution
Distribution in WI, NY, and SD
Recall date
November 24, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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