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U.S. Department of Health and Human Services

Class 3 Device Recall Schiff

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  Class 3 Device Recall Schiff see related information
Date Initiated by Firm July 25, 2006
Date Posted December 27, 2006
Recall Status1 Terminated 3 on October 06, 2008
Recall Number Z-0305-2007
Recall Event ID 36096
Product Classification in vitro diagnostic - Product Code KKS
Product Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests.
Code Information Item Number 64945/93 Lot # 5341, Exp. Date: May 31, 2007.
Recalling Firm/
Manufacturer		 EMD Chemicals Inc
480 S Democrat Rd
Gibbstown NJ 08027-1239
For Additional Information Contact Joseph P. Schoellkopff
856-423-6300
Manufacturer Reason
for Recall		 Due to loose caps, the SO2 levels dropped significantly from release levels causing the product not to perform properly.
FDA Determined
Cause 2		 Other
Action On July 27, 2006 EMD contacted its direct account customers via letter. The firm requested discontinue use of the product and contact EMD for return.
Quantity in Commerce 74 kits
Distribution Nationwide.
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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