Z-2031-2012Class II

BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine...

Name: Z-2031-2012 BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine...
Creator: Becton Dickinson & Co.
Published: 2012-04-12
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-04-12 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram... on 2012-04-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2031-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-12
Posted: 2012-07-18
Terminated: 2012-12-10
Recalling firm: Becton Dickinson & Co
Product: 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.
Product code: JTS Stains, Microbiologic
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated April 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard the affected product. An Acknowledgement Form was attached for customers to complete and return via fax to 410-316-4258. Contact the BD Customer Service Department for questions regarding this recall.
Quantity in commerce: 539 kits
Distribution: Nationwide Distribution.
Product codes and lots: Lot 1348873, Exp April 30, 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2031-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2031-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-18
Z-2032-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-18

Product code JTS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)