Becton Dickinson recalls BD BBLTM Gram Crystal Violet 250mL IVD primary stain for false-positive Gram stains. Affected lots from 05/12/20 to 07/31/21 may cause misdiagnosis of bacteria.
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
Becton Dickinson is recalling BD BBLTM Gram Crystal Violet 250mL staining reagents because they can cause false-positive Gram stain results, potentially leading to incorrect bacterial identification. This affects lab users who rely on these reagents for microbiology testing. Read more at govinfonow.com/recall/65401-bd-bbltm-gram-crystal-violet-250ml-recall-false-positive-gram.
“BD BBLTM Gram Crystal Violet 250mL Recall: False-positive Gram Stain Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65401-bd-bbltm-gram-crystal-violet-250ml-recall-false-positive-gram. Based on FDA recall #Z-2046-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2046-2020%22&limit=1).
The FDA announced on April 14, 2020, that Becton Dickinson & Co. is recalling BD BBLTM Gram Crystal Violet 250mL IVD Primary stain due to potential false-positive Gram stains. The recall affects 10,568 bottles distributed worldwide.
The product may exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci. This issue could result in a false-positive Gram stain.
Context
GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since June 1, 2017. Recent recalls include the BD GasP CO2 Pouch System recall dated April 7, 2026, and the BD Kiestra Isolate Suspension Cuvette Array recall dated October 23, 2025. Other recent recalls of similar products include the Beckman Coulter DxH Diluent Recall (November 10, 2025), the Medline Blood Culture Kit Recall (December 24, 2025), and the Meridian Bioscience Revogene C. difficile Test Recall (December 5, 2025).
How to tell if you have this one
Check the lot number on the reagent bottle, which ranges from 9269800 (expiring 04/30/21) to 9352492 (expiring 07/31/21). The product was sold between May 12, 2020, and the listed expiration dates.
Brand
Becton Dickinson
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
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.
Recall number
Product, codes & lots
Quantity
Z-2046-2020
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.; 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
10,568 bottles
Z-2047-2020
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 to stain microorganisms from cultures or specimens by the differential Gram method.; Lot Number/ Exp Date: 317740 06/30/21; 9296637 05/31/21. Expanded 5/12/20 Lot numbers:: 9296631 05/31/21; 0027824 08/31/21.
236 bottles
Z-2048-2020
BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.; Lot Number/ Exp Date: 0007261 06/30/21; 0007255 05/31/21; 0028309 03/30/21. Expanded 5/12/20-Lot Numbers/Exp. Date: 0041114 07/31/21; 0014322 06/30/21
1469 kits
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for the lot number on the reagent bottle, which is listed in the recall notice as 9269800 through 9352492.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2046-2020 (April 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2046-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.