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.
Recall
- Recall Number
- Z-0978-2010
- Event Number
- 54068
- Firm
- Becton Dickinson & Co.
- FEI Number
- 1119779
- Product Code
- JTO
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- September 28, 2009
- Posted
- March 4, 2010
- Terminated
- March 24, 2010
- Address
- 7 Loveton Cir, Sparks, MD, 21152-9212
Description
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.
An in-vitro diagnostic reagent used by clinical laboratories was mislabeled.
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.
Worldwide distribution: USA and Puerto Rico, Korea, and Singapore.
100 shelf packs