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U.S. Department of Health and Human Services

Class 3 Device Recall SPOTTEST LACTOPHENOL COTTON BLUE STAIN

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 Class 3 Device Recall SPOTTEST LACTOPHENOL COTTON BLUE STAINsee related information
Date Initiated by FirmSeptember 28, 2009
Date PostedMarch 04, 2010
Recall Status1 Terminated 3 on March 24, 2010
Recall NumberZ-0978-2010
Recall Event ID 54068
510(K)NumberK842086 
Product Classification Discs, strips and reagents, microorganism differentiation - Product Code JTO
ProductBBL(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.
Code Information Lot 9111351, exp 01/31/2012
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information ContactCustomer Service Department
800-675-0908
Manufacturer Reason
for Recall		An in-vitro diagnostic reagent used by clinical laboratories was mislabeled.
FDA Determined
Cause 2		Labeling mix-ups
ActionAn "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 Commerce100 shelf packs
DistributionWorldwide distribution: USA and Puerto Rico, Korea, and Singapore.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JTO
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