FDAClass IISeptember 20, 2023

Remel Todd Hewitt W. CNA recall

remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora

Why was Remel Todd Hewitt W. CNA recalled?

On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024

Product
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Recalling firm
Remel, Inc
Quantity
139 units (13,900 tests)
Distribution
US Nationwide Distribution
Recall date
September 20, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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