PlainRecalls
CriticalClass ITerminated

FDA Devices recall · Reported October 15, 2014

Richard-Allan Scientific Bio-Tite Specimen Containers. 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.

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

Recall #
Z-0015-2015
Affected scope
383 cases
Initiated
September 17, 2014
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Richard-Allan Scientific Company recalled Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used … - a critical-severity action.

Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used … was recalled by Richard-Allan Scientific Company in October 15, 2014. Reason: The affected lots could have NBF concentrations that are lower or higher than the desired specifications.. Check the official notice for the remedy. Verify recall #Z-0015-2015 with the FDA Devices before acting.

The recall

Richard-Allan Scientific Company issued this critical-severity FDA Devices recall-The affected lots could have NBF concentrations that are lower or higher than the desired specifications..

Critical
severity level
Class I
classification
October 15, 2014
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0015-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Richard-Allan Scientific Bio-Tite Specimen Containers. 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 for recall

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Terminated
Recall number Z-0015-2015
Date reported October 15, 2014
Date initiated September 17, 2014
Recalling firm Richard-Allan Scientific Company
Firm location Kalamazoo, MI
Affected scope 383 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.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-0015-2015) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
Richard-Allan Scientific Bio-Tite Specimen Containers. 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.. Recalled by Richard-Allan Scientific Company. Units affected: 383 cases.
Why was this product recalled?
The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 15, 2014. Severity: Critical. Recall number: Z-0015-2015.
Where was the recalled product distributed?
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..
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported October 15, 2014. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026