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Recall Observatory FDA recall evidence

Device product

The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.

Z-0801-2013

October 10, 2012

Class II

Product summary

Firm
Remel Inc
Event
Event 63584
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-0801-2013

Official wording

Reason: The product may contain low level microbial contamination which could result in incorrect results.

Code information: Lot 1175209

Distribution pattern: Distribution included the states of IL, IN and MI.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial contamination