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Recall Observatory FDA recall evidence

Device product

CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.

Z-0209-2018

November 02, 2017

Class II

Product summary

Firm
Remel Inc
Event
Event 78470
Status
Terminated
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-0209-2018

Official wording

Reason: Product may have incorrect cation information detailed on the product label.

Code information: Lot 1865331, Exp. 06/2021

Distribution pattern: Distribution was made to AL, MD, ME, NC, and TN. There was no foreign/military/government distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product may have incorrect cation information detailed on the product label.