Z-0978-2010

BBL(tm) Lactophenol Cotton Blue Stain Droppers, Catalog number 261188, shelf package of 50 droppers...

Name: Z-0978-2010 BBL(tm) Lactophenol Cotton Blue Stain Droppers, Catalog number 261188, shelf package of 50 droppers...
Creator: Becton Dickinson & Co.
Published: 2009-09-28
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2009-09-28 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Co. began a recall of BBL(tm) Lactophenol Cotton Blue Stain Droppers, Catalog number 261188, shelf package of 50 droppers, incorrectly labeled in part ***Methylene Blue... on 2009-09-28. The reason FDA records is "An in-vitro diagnostic reagent used by clinical laboratories was mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0978-2010
Status: Terminated
Initiated: 2009-09-28
Posted: 2010-03-04
Terminated: 2010-03-24
Recalling firm: Becton Dickinson & Co
Product: BBL(tm) Lactophenol Cotton Blue Stain Droppers, Catalog number 261188, shelf package of 50 droppers, incorrectly labeled in part ***Methylene Blue Loeffler***Becton Dickinson and Company***Packaged in Mexico*** Lactophenol cotton blue is a blue stain used for direct examination of clinical specimens for fungal elements.
Product code: JTO Discs, Strips And Reagents, Microorganism Differentiation
Reason for recall: An in-vitro diagnostic reagent used by clinical laboratories was mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: An "URGENT PRODUCT RECALL" notice dated September 2009 was issued via UPS letter to customers. The notification letter described the product, problem and the action to be taken by customer. The recalling firm notified distributors and end users to discontinue use of the identified product and discard for replacement. The customers were requested to return an enclosed response form. The customers were requested to provide, within one week, an excel file or a list with name, address and phone number of end-users who were shipped the product from their distribution branches so that the BD may inform them of the issue. For further assistance regarding product replacement contact our Customer Service Department at 1-800-675-0908. For all other inquiries call our Technical Services Department at 1-800-638-8663.
Quantity in commerce: 100 shelf packs
Distribution: Worldwide distribution: USA and Puerto Rico, Korea, and Singapore.
Product codes and lots: Lot 9111351, exp 01/31/2012

Product code JTO

K842086Class ISpottest Lactophenol Cotton Blue StainDifco Laboratories, Inc. / cleared 1984-07-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)