CLASS II Device recall · Reported 25 Jul 2012 · FDA Enforcement Report
BD Gram Stain Kit, containing 1- bottle of Gram Crystal recalled
Becton Dickinson is recalling BD Gram Stain Kit, containing 1- bottle of Gram Crystal Violet, and additional reagents, distributed nationwide in the US. The recall was initiated on 12 Apr 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2031-2012
- FDA event ID
- 61769
- Recalling firm
- Becton Dickinson, Sparks, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Apr 2012
- FDA classified
- 18 Jul 2012
- Reported
- 25 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 12 Apr 2012 | Recall initiated by company | |
| 18 Jul 2012 | Classified by FDA | +97 days |
| 25 Jul 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot 1348873, Exp April 30, 2013
Where was it sold?
Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 61769| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Gram Crystal Violet recalled by Becton Dickinson & | Becton Dickinson | Other | Nationwide |
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