CLASS I Device recall · Reported 15 Oct 2014 · FDA Enforcement Report

Protocol 10% NBF recalled by Richard-Allan Scientific

Richard-Allan Scientific is recalling Protocol 10% NBF, distributed nationwide in the US. The recall was initiated on 17 Sep 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesProduct Code: 426-796 Lot Number: 298987

Quantity recalled175 cases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0012-2015
FDA event ID: 69276
Recalling firm: Richard-Allan Scientific, Kalamazoo, MI
Classification: Class I
Status: Terminated
Recall initiated: 17 Sep 2014
FDA classified: 9 Oct 2014
Reported: 15 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

17 Sep 2014	Recall initiated by company
9 Oct 2014	Classified by FDA	+22 days
15 Oct 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arizona California Colorado Delaware Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri North Carolina Nebraska

Questions about this recall

Is Protocol 10% NBF recalled?

Yes. Richard-Allan Scientific recalled Protocol 10% NBF on 17 Sep 2014. The recall is Class I and its status is Terminated. Recall number Z-0012-2015.

Why was it recalled?

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

Which lots are affected?

Product Code: 426-796 Lot Number: 298987

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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