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

Specimen Transportation System recalled by Richard-Allan Scientific

Richard-Allan Scientific is recalling Specimen Transportation System, 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: 53151 Lot Number: 300143

Quantity recalled264 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-0017-2015
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

Richard-Allan Scientific Specimen Transportation System. 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

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: 53151 Lot Number: 300143

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

Other products in this recall event

6 other products · FDA event 69276

This product is part of a recall event; the main page for the event is Cardinal Health Prefilled Buffered 10% Formalin recalled.

Reported	Class	Recall	Company	Reason	Where
15 Oct 2014	CLASS I	Cardinal Health Prefilled Buffered 10% Formalin recalled	Richard-Allan Scientific	Potency & Assay	Nationwide
15 Oct 2014	CLASS I	Specimen Transportation System recalled by Richard-Allan Scientific	Richard-Allan Scientific	Potency & Assay	Nationwide
15 Oct 2014	CLASS I	Protocol 10% NBF recalled by Richard-Allan Scientific	Richard-Allan Scientific	Potency & Assay	Nationwide
15 Oct 2014	CLASS I	Bio-Tite Specimen Containers recalled by Richard-Allan Scientific	Richard-Allan Scientific	Potency & Assay	Nationwide
15 Oct 2014	CLASS I	10% Neutral Buffered Formalin recalled by Richard-Allan Scientific	Richard-Allan Scientific	Potency & Assay	Nationwide
15 Oct 2014	CLASS I	10% Neutral Buffered Formalin recalled by Richard-Allan Scientific	Richard-Allan Scientific	Potency & Assay	Nationwide

More recalls from Richard-Allan Scientific

All 14

Reported	Class	Recall	Company	Reason	Where
22 Aug 2018Device	CLASS III	EZ Single Cytofunnel Brown, A78710004 recalled	Richard-Allan Scientific	Labeling Errors	Nationwide
10 May 2017Device	CLASS II	Shandon Rapid Chrome Kwik-Diff Kit recalled by Richard-Allan Scientific	Richard-Allan Scientific	Other	24 states
17 Aug 2016Device	CLASS II	Richard Allan Scientific 10% Neutral Buffered Formalin recalled	Richard-Allan Scientific	Other	6 states
13 Apr 2016Device	CLASS III	Paraffin Type 3 For in vitro diagnostic use recalled	Richard-Allan Scientific	Temperature Abuse	12 states
27 May 2015Device	CLASS II	Mucolytic Agent 1 pint recalled by Richard-Allan Scientific	Richard-Allan Scientific	Other	Nationwide

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All 13,778

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16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide