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Terminated

@ Home Strep Test Rapid Strep Test Product Usage: For in-vitro diagnostic use - detection of Strep.

FDA Recall Z-3054-2011 · Posted 2011-08-23

Recalling FirmJay Bird Investments Inc
Recall StatusTerminated
Product CodeGTY
Date Initiated2011-07-06
Date Terminated2012-06-20
Product Quantity7,541

Reason for Recall

Home Strep Test does not qualify as a Class I device and needs pre-market approval.

Firm Action

Jay Bird Investments, Inc. sent a notification letter dated July 6, 2011 to customers. The letter describes the product, problem and the actions to be taken. The customers were instructed to notify retailers and remove the product from the shelves. For questions regarding disposition of the product please contact Myron Bouwhuis at 801-721-3528.

Root Cause

PMA

Distribution Pattern

Nationwide Distribution (USA) including the states of OR and UTAH.

Official Source

View FDA Recall →

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

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