Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 5390...
FDA Device Recall #Z-2351-2016 — Class II — June 13, 2016
Recall Summary
| Recall Number | Z-2351-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 13, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Richard-Allan Scientific Company |
| Location | Kalamazoo, MI |
| Product Type | Devices |
| Quantity | 18 cases |
Product Description
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.
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.
Distribution Pattern
Distributed in the states of FL, PA, NY, MD, CA, and AZ.
Lot / Code Information
Item 53901, Lot 371348, exp date 01APR2020; Item 561201, Lot 371355, exp date 01APR2020
Other Recalls from Richard-Allan Scientific Company
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2749-2018 | Class III | EZ Single Cytofunnel Brown, A78710004 Produc... | Jun 4, 2018 |
| Z-1895-2017 | Class II | Shandon Rapid Chrome Kwik-Diff Kit Part Number:... | Mar 15, 2017 |
| Z-1319-2016 | Class III | Richard-Allan Scientific Paraffin Type 3 For i... | Feb 16, 2016 |
| Z-1640-2015 | Class II | Lerner Laboratories Mucolexx, 1 pint / 473 ml &... | Apr 29, 2015 |
| Z-1639-2015 | Class II | Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l ... | Apr 29, 2015 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.