Formalin, Neutral Buffered
Pathology · 21 CFR 864.4010
Recent MDR events
39 adverse event reports on file
- 10% NEUTRAL BUFFERED FORMALIN PREFILLED CONTAINER, 500 MLJun 5, 2026MalfunctionMedline Industries, Lp25409079
- EPREDIAFeb 5, 2026MalfunctionRichard-allan Scientific Company24268549
- FISHERBRAND 10% NEUTRAL BUFFERED FORMALIN V/V 240 ML FILLED TO 120 MLAug 7, 2025MalfunctionFisher Scientific Company L.l.c22736826
- 480 ML HALF-FILLED 10% NEUTRAL BUFFERED FORMALINAug 7, 2025MalfunctionAzer Scientific, Inc.22736846
- CARDINAL HEALTHMay 15, 2025MalfunctionCardinal Health 200, Llc22024631
- CARDINAL HEALTH PREFILLED FORMALIN SPECIMEN CONTAINER 180MLApr 22, 2025MalfunctionCardinal HealthMW5169418
- PREFILLED FORMALIN SPECIMEN CONTAINER 180MLApr 16, 2025MalfunctionCardinal HealthMW5169124
- PREFILLED FORMALIN SPECIMEN CONTAINER 180MLApr 16, 2025MalfunctionCardinal HealthMW5169125
- PREFILLED FORMALIN SPECIMEN CONTAINER 180MLApr 16, 2025MalfunctionCardinal HealthMW5169126
- CARDINAL HEALTH PREFILLED FORMALIN SPECIMEN CONTAINER 180MLApr 11, 2025MalfunctionCardinal HealthMW5168881
Event type breakdown
Recalls
2 recall events for this product code
- ThermoFisher Scientific Co., LLCTerminatedAug 25, 2008
10% Buffered Formalin Phosphate; Certified
Assay tests on retention sample of 10% Buffered Formalin Phosphate showed it to be 3.417%, which is below the specification of 4-5%.
Z-2159-2008 · View FDA record ↗ - Richard-Allan Scientific CompanyTerminatedUnknown
Richard Allan Scientific 10% Neutral Buffered Formalin,
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.
Z-2351-2016 · View FDA record ↗
Registered firms
35 firms currently registered for this product code
Ricca Chemical Company Llc
POCOMOKE CITY, MD, US
Trajan Scientific Australia Pty Ltd
Ringwood Victoria, AU
Leica Biosystems Richmond, Inc.
Richmond, IL, US
Remel, Inc.
LENEXA, KS, US
Sensor Health Products, Inc.
CAMBRIDGE Ontario, CA
Azer Scientific, Inc.
Morgantown, PA, US
Eng Scientific Llc
New Brunswick, NJ, US
Scytek Laboratories, Inc.
LOGAN, UT, US
Avantor Performance Materials, Llc
Paris, KY, US
Merck Kgaa
DARMSTADT Hesse, DE
Globe Scientific, Llc
Mahwah, NJ, US
Simport Scientific Inc.
BELOEIL Quebec, CA
Precision Medical Devices Inc
New Brunswick, NJ, US
Calibrescientific Us, Inc.
VANCOUVER, WA, US
Rocky Mountain Reagents, Inc.
Golden, CO, US
Les Plastiques Mdj Inc.
Saint-Hubert Quebec, CA
Ricca Chemical Company Llc
ARLINGTON, TX, US
Worldwide Supplies Limited
Hong Kong, HK
Slmp Llc D.b.a. Statlab Medical Products
McKinney, TX, US
Cancer Diagnostics, Inc.
Durham, NC, US
Anatech Division Of Cancer Diagnostics, Inc.
Battle Creek, MI, US
Newcomer Supply Inc
Waunakee, WI, US
Ricca Chemical Company Llc
BATESVILLE, IN, US
Creative Waste Solutions, Inc.
Tualatin, OR, US
Medical Chemical Corporation
TORRANCE, CA, US
510(k) clearances
15 clearances for this product code
- Donald L. Price, Ph.D.Jan 10, 1989
K884755 · CONSED FECAL CONCENTRATION SYSTEM
- Anatech, Ltd.Aug 6, 1987
K872663 · DRY-FORM
- Medical Specialties, Inc.Jun 15, 1987
K872140 · (MSI) PATH-SAVER
- Anatech, Ltd.Mar 31, 1987
K870852 · NBF 10% NEUTRAL BUFFERED FORMALIN
- Surgipath Medical Industries, Inc.Aug 28, 1985
K853497 · PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN
- Reagent Laboratory, Inc.Oct 1, 1984
K842982 · FORMALIN BUFFERED
- Anatech, Ltd.Aug 28, 1984
K842940 · CBA FORMALIN
- E K Ind., Inc.Aug 3, 1984
K842728 · BUF-FIX