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Pathology devices
83 product codes reviewed by the Pathology panel. 344 510(k) clearances and 257 recalls in the FDA data, 4% of those recalls name a 510(k).
12510(k)s in 12 months
23recalls in 12 months
10recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| MVU | Reagents, Specific, Analyte | 43 | 1 |
| KPA | Slide Stainer, Automated | 30 | 0 |
| PPM | General Purpose Reagent | 30 | 4 |
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | 29 | 9 |
| FMH | Container, Specimen, Sterile | 21 | 3 |
| KDT | Container, Specimen Mailer And Storage, Sterile | 17 | 0 |
| IEO | Processor, Tissue, Automated | 11 | 0 |
| IDP | Microtome, Cryostat | 10 | 0 |
| LDY | Fixative, Formalin-Containing | 7 | 0 |
| NYQ | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer | 6 | 0 |
| QDS | Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System | 6 | 1 |
| KEY | Stainer, Tissue, Automated | 5 | 0 |
| LEA | Preservative, Cytological | 4 | 1 |
| NNI | Container, Specimen, Non-Sterile | 4 | 1 |
| JCB | Detergent | 3 | 0 |
Active product codes
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | 1 | 0 | 9 |
| PSY | Whole Slide Imaging System | 2 | 4 | 1 |
| PPM | General Purpose Reagent | 1 | 0 | 4 |
| FMH | Container, Specimen, Sterile | 1 | 0 | 3 |
| QKQ | Digital Pathology Image Viewing And Management Software | 2 | 3 | 0 |
| SHW | Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis | 2 | 2 | 0 |
| LEA | Preservative, Cytological | 1 | 0 | 1 |
| MVU | Reagents, Specific, Analyte | 1 | 0 | 1 |
| NNI | Container, Specimen, Non-Sterile | 1 | 0 | 1 |
| OIE | Urine Collection Kit (Excludes Hiv Testing) | 1 | 0 | 1 |
| PZM | Next Generation Sequencing Based Tumor Profiling Test | 2 | 1 | 0 |
| QDS | Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System | 2 | 0 | 1 |
| QYV | Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm | 2 | 0 | 1 |
| SBY | High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids | 2 | 1 | 0 |
| SIX | Digital Pathology Image Artifact Detection Software Device | 2 | 1 | 0 |
Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 13, 2026 | BioFire Diagnostics, LLC Generic Name: FilmArray Pneumonia Panel plus
Generic Name: FilmArray Pneumonia Panel plus
Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit)
Software Version: N/A
Product Description: Open, Classified |
QDS | K243222 |
| Oct 2, 2026 | Medical Action Industries, Inc. 306 Generic Name: Kit, Urine, Clean Catch
Trade Name: Kit: Urinary Clean Catch 20/cs
Model/Catalog Number: 76769
Lot Number: 333606
UDI-DI: 20809160118228
Software Version: N/A Open, Classified |
OIE | None listed |
| Sep 14, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DYNDB3086D, Catalog Number: DYNDB3086D;
2) DYNDB3100, Catalog Number: DYNDB3100;
3) DYNDH1619A, Catalog Number: DYNDH1619A;
4) DYNDH1620A, Catalog Number: DYNDH1620A;
Open, Classified |
OIB | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) BLOOD DRAW KIT, Catalog Number: DYLAB1081;
2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number: DYNDB3005D;
3) QP KIT, Catalog Number: DYNDB3005F;
4) DOUBLE RED CELL PHLEBOTO Open, Classified |
OIB | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
ADULT BLOOD CULTURE KIT
DYNDH1444D
BLOOD CULTR KT DIVRSN DEVICE
DYNDH1866
BLOOD CULTURE KIT
DYNDH1462B
DYNDH1622C
D Open, Classified |
OIB | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920;
2) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920A Open, Classified |
OIB | None listed |
| Aug 7, 2026 | Ventana Medical Systems, Inc. navify Digital Pathology (on-prem) v2.5, Material Number 10092343001
navify Digital Pathology (Cloud) v2.5. Material Number 09453733001
UDI-DI Code: 761333602095AQ
In the United States, navify Dig Open, Classified |
PSY | K232879 K242783 |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A Open, Classified |
FMH | None listed |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) WMC I D PACK-LF, Model Number: DYNJ50806L Open, Classified |
OIB | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:
1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520;
2. BLOOD DRAW KIT, Medline Kit SKU EBSI1317. Open, Classified |
OIB | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I Open, Classified |
FMH | None listed |
| Apr 29, 2026 | Immuno-Mycologics, Inc Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60
For processing of clinical specimens for Mycobacterium spp. diagnosis Open, Classified |
PPM | None listed |
| Apr 24, 2026 | Milestone S.R.L. VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS Open, Classified |
NNI | None listed |
| Apr 24, 2026 | Hologic, Inc Brand Name: Genius" Review Station
Product Name: Genius" Review Station Display (Barco Monitor)
Model/Catalog Number: CMP-01669
Software Version: N/A - not software version specific
Component: Yes, th Open, Classified |
QYV | None listed |
| Apr 22, 2026 | LSL Healthcare Inc. LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555 Open, Classified |
OIB | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A Open, Classified |
FMH | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) WMC I D PACK-LF, Model Number: DYNJ50806L Open, Classified |
OIB | None listed |
| Feb 9, 2026 | Medline Industries, LP Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088 Open, Classified |
OIB | None listed |
| Jan 15, 2026 | Hologic, Inc ThinPrep CytoLyt Solution. Buffered Cell Wash Solution. Open, Classified |
LEA | None listed |
| Dec 18, 2025 | Copan Italia 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk Open, Classified |
PPM | None listed |
| Dec 18, 2025 | Copan Italia 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP*
*Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System Open, Classified |
PPM | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Akkermansia Test Open, Classified |
PPM | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Herpes (HSV-1 & HSV-2) Test Open, Classified |
MVU | None listed |
| Jul 21, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as:
1) BLOOD CULTURE KIT, REF DYNDH1462B;
2) BLOOD CULTURE KIT, REF DYNDH1622C;
3) BLOOD CULTR KT DIVRSN DEVICE, Open, Classified |
OIB | None listed |
| Jun 18, 2025 | Diagnostica Stago, Inc. STA - Owren Koller. Model/Catalog Number: 00360
STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of t Open, Classified |
PPM | None listed |
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