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Recall Observatory FDA recall evidence

Device product

Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.

Z-0578-2015

November 13, 2014

Class II

Product summary

Firm
Remel Inc
Event
Event 69771
Status
Terminated
Classification
Class II
Quantity
1/10/100 ml/vials/packs
Official record key
device-enforcement:Z-0578-2015

Official wording

Reason: Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.

Code information: Lot number: 1374439, Exp: 31 Aug 2015

Distribution pattern: Nationwide Distribution to FL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.