RecallRadar

FDA Device recall Z-0012-2015

Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination

On 2014-10-15 the FDA classified a Class I recall of Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination by Richard Allan Scientific, citing the affected lots could have NBF concentrations that are lower or higher than the desired specifications.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0012-2015
ClassificationClass I
Statusterminated
Initiated2014-09-17
Published2014-10-15
Last updated2026-09-13 11:53 UTC
CompanyRichard Allan Scientific
DistributionUS

Product

Protocol 10% NBF 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.

Reason

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

Identifiers

code_infoProduct Code: 426-796 Lot Number: 298987

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0012-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.