FDA Recall Terminated

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.

Recall: Z-0653-03 · Initiated December 12, 2002

Recall

Recall Number
Z-0653-03
Event Number
25233
Firm
Simmler Inc
FEI Number
1950226
Status
Terminated
Root Cause
Other
Initiated
December 12, 2002
Posted
March 20, 2003
Terminated
August 16, 2004
Address
4156 Hoffmeister, St Louis, MO, 63125

Description

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.

Reason

Fixing solution bottles are labeled as buffering solution.

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.

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.

Quantity

352 kits