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Terminated

Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

FDA Recall Z-0014-2015 · Posted 2014-10-09

Recalling FirmRichard-Allan Scientific Company
Recall StatusTerminated
Product CodeLDY
Date Initiated2014-09-17
Date Terminated2016-10-27
Product Quantity80 cases

Reason for Recall

The affected lots could have NBF concentrations that are lower or higher than the desired specifications.

Firm Action

The firm issued an "URGENT MEDICAL DEVICE RECALL" letter to all affected customers. The notification identified the affected products, reason for voluntary recall, risk to health, actions to be taken, and instructions to complete the attached Acknowledgement Form. For questions, contact Sarah Rickert at 269-544-5628 or [email protected].

Root Cause

Mixed-up of materials/components

Distribution Pattern

Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.

Official Source

View FDA Recall →

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

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