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Class 2 Device Recall Fetal Cell Stain Kit |
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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
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Manufacturer Reason for Recall |
Fixing solution bottles are labeled as buffering solution.
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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. |
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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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