Home › Device types › PPM
General Purpose Reagent
FDA product code PPM · Class 1 · Pathology
1,294
Registered devices
317
Adverse events
30
Recalls
16
510(k) clearances
Devices with this code
Epredia — RICHARD-ALLAN SCIENTIFIC COMPANYDiagnostic BioSystems — Diagnostic Biosystems, Inc.0.2M NaCl filled in 20L Flexsafe bag — Lonza VerviersDiagnostic BioSystems — Diagnostic Biosystems, Inc.FluoroMounter — BIO SB, INC.Vysis — ABBOTT MOLECULAR INC.Carezyme II: Pepsin — BIOCARE MEDICAL LLCVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.MGB Alert Platinum Master Mix with water-480rxn — Elitechgroup Mdx LLCStabilized NBT/BCIP 50ml bottle - sample — Lonza VerviersDiagnostic BioSystems — Diagnostic Biosystems, Inc.REMEL — REMEL, INC.EDGE BIOLOGICALS INC — EDGE BIOLOGICALS, INC.Genemed® — SAKURA FINETEK U.S.A., INC.BOND — LEICA BIOSYSTEMS NEWCASTLE LTDBackground Eraser — BIOCARE MEDICAL LLCImmunoRetriever 20X with EDTA — BIO SB, INC.Vysis — ABBOTT MOLECULAR INC.IMMAGE — Beckman Coulter, Inc.EUROSORB (IFA) — EUROIMMUN Medizinische Labordiagnostika AGQIAGEN Proteinase K — QIAGEN GmbHEDGE BIOLOGICALS INC — EDGE BIOLOGICALS, INC.Vysis — ABBOTT MOLECULAR INC.Alpha-Tec Systems — Alpha-TEC Systems, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-26 | Immuno-Mycologics, Inc | Neutralization Buffer may contain contaminants |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-10-29 | Copan Italia | Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed. |
| 2025-10-29 | Copan Italia | Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed. |
| 2025-05-21 | Diagnostica Stago, Inc. | Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1% |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con |
| 2024-09-25 | Biocare Medical, LLC | Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no s |
| 2024-05-21 | Ortho-Clinical Diagnostics, Inc. | VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemis |
| 2024-02-07 | Beckman Coulter, Inc. | On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289 |
| 2023-05-24 | NeuMoDx Molecular Inc | Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into |
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