Recall Z-0978-2010 ยท JTO Discs, Strips And Reagents, Microorganism Differentiation
Becton Dickinson & Co.
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.
| Date | Mar 4, 2010 (initiated Sep 28, 2009) |
| Status | Terminated |
| Reason | An in-vitro diagnostic reagent used by clinical laboratories was mislabeled. |
| 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 |
| Quantity | 100 shelf packs |
| Distribution | Worldwide distribution: USA and Puerto Rico, Korea, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842086 | SPOTTEST LACTOPHENOL COTTON BLUE STAIN Difco Laboratories, Inc., Jul 3, 1984 |