BBL(tm) Lactophenol Cotton Blue Stain Droppers, Catalog number 261188, shelf package of 50 droppers, incorrectly labeled
FDA device recall Z-0978-2010 · posted 2010-03-04 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- An in-vitro diagnostic reagent used by clinical laboratories was mislabeled.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JTO
- Quantity affected
- 100 shelf packs
- Distribution
- Worldwide distribution: USA and Puerto Rico, Korea, and Singapore.
- Date initiated
- 2009-09-28
- Date posted
- 2010-03-04
- Date terminated
- 2010-03-24
- Location
- Sparks, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPOTTEST LACTOPHENOL COTTON BLUE STAIN (K842086) | Difco Laboratories, Inc. | 1984-07-03 |