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Recall Observatory FDA recall evidence

Device product

Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.

Z-1571-2016

March 21, 2016

Class II

Product summary

Firm
Hardy Diagnostics
Event
Event 73688
Status
Terminated
Classification
Class II
Quantity
3,530 (353 pk/10)
Official record key
device-enforcement:Z-1571-2016

Official wording

Reason: Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration.

Code information: Lot H16054 and H15056.

Distribution pattern: U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration.