CLASS II Device recall · Reported 17 Aug 2016 · FDA Enforcement Report
Richard Allan Scientific 10% Neutral Buffered Formalin recalled
Richard-Allan Scientific is recalling Richard Allan Scientific 10% Neutral Buffered Formalin, distributed in Arizona, California, Florida, Maryland, New York, Pennsylvania. The recall was initiated on 13 Jun 2016 and the FDA has classified it as Class II.
Check your package
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-2351-2016
- FDA event ID
- 74557
- Recalling firm
- Richard-Allan Scientific, Kalamazoo, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jun 2016
- FDA classified
- 5 Aug 2016
- Reported
- 17 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 13 Jun 2016 | Recall initiated by company | |
| 5 Aug 2016 | Classified by FDA | +53 days |
| 17 Aug 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. It is unknown whether the contamination will affect tissue antigenicity. If it were to affect tissue antigenicity, the outcome would be risk of false positive or false negative test results which may lead to serious injury. There is the possibility the patient may need to be re-biopsied.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per case; Item 561201 120ml bottle, 75 per case.
Where it was distributed
Distributed in the states of FL, PA, NY, MD, CA, and AZ.
Questions about this recall
Is Richard Allan Scientific 10% Neutral Buffered Formalin recalled?
Yes. Richard-Allan Scientific recalled Richard Allan Scientific 10% Neutral Buffered Formalin on 13 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-2351-2016.
Why was it recalled?
potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. It is unknown whether the contamination will affect tissue antigenicity. If it were to affect tissue antigenicity, the outcome would be risk of false positive or false negative test results which may lead to serious injury. There is the possibility the patient may need to be re-biopsied.
Which lots are affected?
Item 53901, Lot 371348, exp date 01APR2020; Item 561201, Lot 371355, exp date 01APR2020
Where was it sold?
Distributed in the states of FL, PA, NY, MD, CA, and AZ.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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