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U.S. Department of Health and Human Services

Class 2 Device Recall 10 Buffered Formalin Phosphate

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  Class 2 Device Recall 10 Buffered Formalin Phosphate see related information
Date Initiated by Firm May 01, 2008
Date Posted August 25, 2008
Recall Status1 Terminated 3 on August 13, 2012
Recall Number Z-2159-2008
Recall Event ID 48601
Product Classification Neutral Buffered Formalin - Product Code IFP
Product 10% Buffered Formalin Phosphate; Certified
For laboratory and manufacturing use only, not for drug, food or household use.
Do not Transfer to an unmarked container.
Catalog numbers: SF100-4, SF100-20
Fisher Scientific, Fail Lawn, NJ 07410
Code Information Lot 075923
Recalling Firm/
Manufacturer		 ThermoFisher Scientific Co., LLC
1 Reagent Ln
Fair Lawn NJ 07410-2802
For Additional Information Contact Deva Puranam
201-703-3185
Manufacturer Reason
for Recall		 Assay tests on retention sample of 10% Buffered Formalin Phosphate showed it to be 3.417%, which is below the specification of 4-5%.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Urgent: Product Recall notification letters were sent by US mail on May 1, 2008. The letters asked that those in receipt of the product check their stock for this product, destroy any of the material that remains from the referenced lot, and then contact their local customer service center for a replacement. The letter also states that the appropriate corrective measures have already been instituted to prevent a recurrence.
Quantity in Commerce 1052 x 4 liters, 564 x 20 liters
Distribution Worldwide Distribution --- including USA and Canada.
Total Product Life Cycle TPLC 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.
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