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Recall Observatory FDA recall evidence

Device product

Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

Z-2032-2012

April 12, 2012

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 61769
Status
Terminated
Classification
Class II
Quantity
878 cartons/ 3512 bottles
Official record key
device-enforcement:Z-2032-2012

Official wording

Reason: Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.

Code information: Lots 1325324 Exp May 31,2013 and 2011746, Exp July 31,2013

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.