Z-0012-2015Class I

Protocol 10% NBF

Name: Z-0012-2015 Protocol 10% NBF
Creator: Richard-Allan Scientific Company
Published: 2014-09-17
License: https://open.fda.gov/license/

Richard-Allan Scientific LLC / initiated 2014-09-17 / Terminated

FDA source

Richard-Allan Scientific Company began a recall of 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... on 2014-09-17. FDA classified it as Class I and gives the reason as "The affected lots could have NBF concentrations that are lower or higher than the desired specifications". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0012-2015
Classification: Class I
Status: Terminated
Initiated: 2014-09-17
Posted: 2014-10-09
Terminated: 2016-10-27
Recalling firm: Richard-Allan Scientific LLC
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.
Product code: LDY Fixative, Formalin-Containing
Reason for recall: The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
FDA root cause: Mixed-up of materials/components
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].
Quantity in commerce: 175 cases
Distribution: 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.
Product codes and lots: Product Code: 426-796 Lot Number: 298987

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0012-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0012-2015	Class I	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-09
Z-0013-2015	Class I	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-09
Z-0014-2015	Class I	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-09
Z-0015-2015	Class I	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-09
Z-0016-2015	Class I	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-09
Z-0017-2015	Class I	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-09
Z-0018-2015	Class I	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-09

Product code LDY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)