—#87349

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.

FDA product code: JTO — Discs, Strips And Reagents, Microorganism Differentiation
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K842086
Affected lot / code info: Lot 9111351, exp 01/31/2012

Why it was recalled

An in-vitro diagnostic reagent used by clinical laboratories was mislabeled.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: Worldwide distribution: USA and Puerto Rico, Korea, and Singapore.

Timeline

Recall initiated: 2009-09-28
Posted by FDA: 2010-03-04
Terminated: 2010-03-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87349. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.