Stains, Microbiologic
Hematology · 21 CFR 864.1850
Recent MDR events
253 adverse event reports on file
- BD BBL¿ GRAM STAIN KITApr 2, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-00601
- BBLJan 28, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-00027
- BBLJan 27, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-00026
- BD BBL¿ GRAM CRYSTAL VIOLETJan 26, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-00025
- BD BBL¿ GRAM SAFRANINJan 23, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-00024
- BD BBL¿ GRAM SAFRANINJan 23, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-00023
- BD BBL¿ TB FLUORESCENT STAIN KIT M CONTAINSJan 16, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-05563
- BD BBL¿ TB FLUORESCENT STAIN KIT M CONTAINSJan 16, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-00010
- BD BBL¿ TB FLUORESCENT STAIN KIT M CONTAINSJan 16, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-00014
- BD BBL¿ TB FLUORESCENT STAIN KIT M CONTAINSJan 16, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-00012
Event type breakdown
Recalls
9 recall events for this product code
- Becton Dickinson & Co.Open, ClassifiedMar 6, 2025
BD BBL TB Stain Kit K, Catalog (REF): 212522
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.
Z-1296-2025 · View FDA record ↗ - Remel IncTerminatedNov 25, 2014
Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg.
The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
Z-0449-2015 · View FDA record ↗ - Becton Dickinson & Co.TerminatedJul 18, 2012
BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin.
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.
Z-2031-2012 · View FDA record ↗ - Becton Dickinson & Co.TerminatedJul 18, 2012
Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles.
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.
Z-2032-2012 · View FDA record ↗ - Becton Dickinson & Co.TerminatedOct 20, 2004
Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.
Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples.
Z-0025-05 · View FDA record ↗ - Becton Dickinson & Co.TerminatedUnknown
BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are use
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 stain
Z-2046-2020 · View FDA record ↗ - Becton Dickinson & Co.TerminatedUnknown
BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagents are used
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 stain
Z-2047-2020 · View FDA record ↗ - Becton Dickinson & Co.TerminatedUnknown
BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reag
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 stain
Z-2048-2020 · View FDA record ↗ - BioMerieux SATerminatedUnknown
Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method.
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 distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
Z-2171-2018 · View FDA record ↗
Registered firms
42 firms currently registered for this product code
Rr Donnelley Global Turnkey Solutions
Juarez Chihuahua, MX
Azer Scientific, Inc.
Morgantown, PA, US
Remel, Inc.
LENEXA, KS, US
Richard-allan Scientific Llc
KALAMAZOO, MI, US
Calibrescientific Us, Inc.
VANCOUVER, WA, US
Bio-gram Diagnostics Gmbh
Worms Rhineland-Palatinate, DE
Biomerieux Sa
LA BALME LES GROTTES Isere, FR
Mdd Options, Llc
New Hill, NC, US
Rocky Mountain Reagents, Inc.
Golden, CO, US
Chaptec America
Montreal Quebec, CA
Ventana Medical Systems, Inc.
Tucson, AZ, US
Ral Diagnostics
Martillac Gironde, FR
Hardy Diagnostics
Orcutt, CA, US
Teco Diagnostics
ANAHEIM, CA, US
Microbiologics, Inc.
LEXINGTON, KY, US
E K Industries, Inc.
JOLIET, IL, US
Dagatronics Corporation
Goyang Gyeonggi, KR
Becton, Dickinson & Co.
SPARKS, MD, US
510(k) clearances
40 clearances for this product code
- Remel Co.Mar 19, 1996
K960095 · BACTIDROP CALCOFLUOR WHITE
- Remel Co.Mar 19, 1996
K960090 · CALCOFLUOR WHITE STAIN KIT
- Remel Co.Jun 9, 1992
K920976 · BACTIDROP INDIA INK
- Remel Co.Jun 9, 1992
K920975 · BACTIDROP CALCOFLUOR WHITE
- Remel Co.Jun 9, 1992
K920970 · BACTIDROP KOH (10%)
- Intl. Remote Imaging SystemsJun 13, 1989
K893530 · IRISTAIN FORMULA 2, PARTS 1 AND 2
- Alpha-Tec Systems, Inc.Mar 23, 1989
K890861 · ATS DOBELL & O'CONNOR'S IODINE
- Alpha-Tec Systems, Inc.Feb 24, 1989
K890020 · ATS LUGOL'S IODINE SOLUTION