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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.

FDA Recall Z-0653-03 · Posted 2003-03-20

Recalling FirmSimmler Inc
Recall StatusTerminated
Date Initiated2002-12-12
Date Terminated2004-08-16
Product Quantity352 kits

Reason for Recall

Fixing solution bottles are labeled as buffering solution.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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