CLASS II Device recall · Reported 27 May 2020 · FDA Enforcement Report
BD Bbltm Gram Crystal Violet-- IVD Primary stain recalled
Becton Dickinson & is recalling BD Bbltm Gram Crystal Violet-- IVD Primary stain for Staining Microorganisms, distributed nationwide in the US. The recall was initiated on 14 Apr 2020 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-2046-2020
- FDA event ID
- 85508
- Recalling firm
- Becton Dickinson &, Sparks, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Apr 2020
- FDA classified
- 19 May 2020
- Reported
- 27 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 14 Apr 2020 | Recall initiated by company | |
| 19 May 2020 | Classified by FDA | +35 days |
| 27 May 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Product as listed by the FDA
BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Canada, Taiwan, Hong Kong, Chile, EMEA, Thailand, China, Japan, Australia, New Zealand, Korea, Costa Rica, Mexico, Canada, and Singapore.
Questions about this recall
Is BD Bbltm Gram Crystal Violet-- IVD Primary stain for Staining Microorganisms recalled?
Yes. Becton Dickinson & recalled BD Bbltm Gram Crystal Violet-- IVD Primary stain for Staining Microorganisms on 14 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2046-2020.
Why was it recalled?
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
Which lots are affected?
Lot Number/ Exp Date: 9269800 04/30/21; 9296589 05/31/21; 9317733 06/30/21; 9352487 07/31/21; Expanded 05/12/20- Lot Numbers: 9352484 07/31/21 9352492 07/31/21
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Canada, Taiwan, Hong Kong, Chile, EMEA, Thailand, China, Japan, Australia, New Zealand, Korea, Costa Rica, Mexico, Canada, and Singapore.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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