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U.S. Department of Health and Human Services

Class 2 Device Recall Fetal Cell Stain Kit

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  Class 2 Device Recall Fetal Cell Stain Kit see related information
Date Initiated by Firm December 12, 2002
Date Posted March 20, 2003
Recall Status1 Terminated 3 on August 16, 2004
Recall Number Z-0653-03
Recall Event ID 25233
Product Fetal Cell Stain Kit No. S0412-00, contents include 3 x 120ml Fetal Cell Fixing Solution (80% Reagent Alcohol), 3 x 120ml Fetal Cell Citrate Buffer Solution (Citrate Buffer, 0.081M), and 3 x 120ml Fetal Cell Stain (Erythrosin-B, Fast Green). The responsible firm on the label is Simmler, Inc., St. Louis, MO.
Code Information Lot #92558, Exp. March, 2004
Recalling Firm/
Manufacturer		 Simmler Inc
4156 Hoffmeister
St Louis MO 63125
Manufacturer Reason
for Recall		 Fixing solution bottles are labeled as buffering solution.
FDA Determined
Cause 2		 Other
Action Recall letters dated 12/12/02 were issued via regular mail on 12/18/02 requesting the customer to examine the contents of the kit. If mislabeled bottles are found, they were instructed to return the kit.
Quantity in Commerce 352 kits
Distribution Distribution was made to hospitals and distributors nationwide. Foreign distribution was made to hospitals in Canada. Military distribution was made to hospitals in KY, OH, and Japan.
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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