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REMEL
REMEL, INC. · Model R40124 · UDI-DI 00848838031335
10
510(k) clearances
253
Adverse events
9
Recalls
32
Facilities
Description
Sulfuric Acid (1%) BTL/250ml
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 false-positive Gram stai |
| 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 false-positive Gram stai |
| 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 false-positive Gram stai |
| 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 asked the bioMrieux di |
| 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 cocci. |
| 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 cocci. |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.