Richard-Allan Scientific LLC
Kalamazoo, MI, US
RICHARD-ALLAN SCIENTIFIC LLC appears in FDA device records in Kalamazoo, MI. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 15 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1831638 | 1831638 | RICHARD-ALLAN SCIENTIFIC LLC | 4481 CAMPUS DR., KALAMAZOO, MI 49008 US | 2026 | and 49 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KKSAcid, Periodic
- KEMAgent, Clearing
- IDAAlcian Blue
- KFDAniline Blue
- KKWBasic Fuchsin
- ICNBiebrich Scarlet
- ICLCarbol Fuchsin
- IDZCassettes, Tissue
- ICHCongo Red
- KERContainer, Embedding
- NNIContainer, Specimen, Non-Sterile
- ICFCrystal Violet For Histology
- IFBCytocentrifuge
- HYBEosin Y
- HYCFast Green
- LDWFixative, Acid Containing
- LDZFixative, Alcohol Containing
- LDYFixative, Formalin-Containing
- IGNFluid, Bouin'S
- IFPFormalin, Neutral Buffered
- KEOFormulations, Paraffin, All
- PPMGeneral Purpose Reagent
- HYFGiemsa Stain
- HYHGold Chloride
- HYJHematoxylin
- HYKHematoxylin Harris'S
- HYLHematoxylin Mayer'S
- IAEHematoxylin, Iron, Weigert'S
- MYAImmunohistochemistry Antibody Assay, Estrogen Receptor
- MXZImmunohistochemistry Assay, Antibody, Progesterone Receptor
- NJTImmunohistochemistry Reagents And Kits
- HYIIodine, Grams
- GGHIron Stains
- KJXJenner Stain
- KEQMedia, Mounting, Water Soluble
- HYZMethenamine Silver
- HZAMethyl Green
- KFCMethylene Blue, Tissue Stain
- IDLMicrotome, Accessories
- LEBMounting Media
- HZCMucicarmine
- HZFNuclear Fast Red
- JCCPh Buffer
- IFLPolyethylene Glycol Preservative
- LEAPreservative, Cytological
- HZTReagent, Schiff
- HZSSafranin
- KDXSolution, Decalcifier, Acid Containing
- IGDSolution, Formol Calcium
- HZJStain, Papanicolau
- GJHStain, Reticulocyte
- HYWStain, Trichrome, Mallory'S
- LEDStains, Chemical Solution
- LEFStains, Dye Powder
- LEEStains, Dye Solution
- KQCStains, Hematology
- JTSStains, Microbiologic
- IACVan Gieson'S Stain
- IAFWright'S Stain
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2749-2018 | EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin. | Mislabeled product | Class III | Terminated | |
| Z-1895-2017 | Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as a reagent in a 4L bottle. Intended for use as a kit in special stain techniques. | Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead. | Class II | Terminated | |
| Z-2351-2016 | 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. | 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. | Class II | Terminated | |
| Z-1319-2016 | Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific" Richard-Allan Scientific" Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, colorless liquid when molten. The paraffin is highly quality controlled and can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. The paraffin should be stored in a cool, dry place | Multiple complaints were received from customers indicating that they ordered product 8335(Type 3 Paraffin) but when they opened the box, they found product 8336 (Type 6 Paraffin) inside. | Class III | Terminated | |
| Z-1640-2015 | Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results. | Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots of Mucolexx. | Class II | Terminated | |
| Z-1639-2015 | Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results. | Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots of Mucolexx. | Class II | Terminated | |
| Z-1264-2015 | Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific. | The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and EXP date 11/2016. The gallon bottle contains the correct intended contents of 7501R: Cyto-Stain R Stain. | Class III | Terminated | |
| Z-0018-2015 | Cardinal Health Prefilled Buffered 10% Formalin. 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. | Class I | Terminated | |
| Z-0017-2015 | 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. | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. | Class I | Terminated | |
| Z-0016-2015 | Richard-Allan Scientific 10% Neutral Buffered Formalin. 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. | Class I | Terminated | |
| Z-0015-2015 | 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. | Class I | Terminated | |
| Z-0014-2015 | Richard-Allan Scientific 10% Neutral Buffered Formalin. 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. | Class I | Terminated | |
| Z-0013-2015 | Richard-Allan Scientific Specimen Transportation System. 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. | Class I | Terminated | |
| Z-0012-2015 | Protocol 10% NBF 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. | Class I | Terminated | |
| Z-0039-2012 | Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks. | The firm has received two complaints of finger lacerations in operators of this device. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain