FDAClass IISeptember 19, 2018

Remel Thioglycollate Medium W/o Indicator. W/ Dextrose recall

remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702

Why was Remel Thioglycollate Medium W/o Indicator. W/ Dextrose recalled?

Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.

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?

(a) 9ML, REF 064700, Lot numbers: 254751, 259508, 272498 (b) 10ML, REF 07176, Lot numbers: 259521 (c) 9ML, REF 064702, Lot numbers: 274247

Product
remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702
Recalling firm
Remel Inc
Quantity
384 units
Distribution
US, Canada, Singapore
Recall date
September 19, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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