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Terminated

Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture

FDA Recall Z-1911-2016 · Posted 2016-06-03

Recalling FirmIntegrated Science Systems Inc
Recall StatusTerminated
Product CodeLHJ
Date Initiated2016-02-19
Date Terminated2017-02-28
Product Quantity2625 kits

Reason for Recall

Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.

Firm Action

Integrated Science Systems sent a Recall Notification letter dated March 29, 2016. Integrated Science Systems requested that unopened kits in inventory be returned. Once the root cause has been determined, the kits will be reworked and returned to INOVA for distribution. For questions call 706-922-8686.

Root Cause

Process control

Distribution Pattern

Nationwide distribution to CA only.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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