Home › Device types › JTS
Stains, Microbiologic
FDA product code JTS · Class 1 · Hematology
148
Registered devices
253
Adverse events
9
Recalls
40
510(k) clearances
Devices with this code
REMEL — REMEL, INC.REMEL — REMEL, INC.REMEL — REMEL, INC.REMEL — REMEL, INC.N/A — Scientific Device Laboratory, Inc.N/A — Scientific Device Laboratory, Inc.REMEL — REMEL, INC.PREVI® Color Gram RB IODINE solution — BIOMERIEUX SAAlpha-Tec Systems — Alpha-TEC Systems, Inc.REMEL — REMEL, INC.BD BBL™ TB Methylene Blue — BECTON, DICKINSON AND COMPANYIndia Ink — MICROBIOLOGICS INC.REMEL — REMEL, INC.India Ink — MICROBIOLOGICS INC.N/A — Scientific Device Laboratory, Inc.India Ink — MICROBIOLOGICS INC.REMEL — REMEL, INC.BD BBL™ Calcofluor White Reagent Droppers — BECTON, DICKINSON AND COMPANYAlpha-Tec Systems — Alpha-TEC Systems, Inc.REMEL — REMEL, INC.Epredia — RICHARD-ALLAN SCIENTIFIC COMPANYN/A — Scientific Device Laboratory, Inc.N/A — Scientific Device Laboratory, Inc.N/A — Scientific Device Laboratory, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-12 | Becton Dickinson & Co. | One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025. |
| 2020-04-14 | Becton Dickinson & Co. | May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a fals |
| 2020-04-14 | Becton Dickinson & Co. | May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a fals |
| 2020-04-14 | Becton Dickinson & Co. | May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a fals |
| 2018-03-23 | BioMerieux SA | A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA as |
| 2014-10-29 | Remel Inc | The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease. |
| 2012-04-12 | Becton Dickinson & Co. | Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocc |
| 2012-04-12 | Becton Dickinson & Co. | Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocc |
| 2004-09-29 | Becton Dickinson & Co. | Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples. |
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