Z-0653-03

Fetal Cell Stain Kit No. S0412-00, contents include 3 x 120ml Fetal Cell Fixing Solution (80% Reagent...

Name: Z-0653-03 Fetal Cell Stain Kit No. S0412-00, contents include 3 x 120ml Fetal Cell Fixing Solution (80% Reagent...
Creator: Simmler Inc
Published: 2002-12-12
License: https://open.fda.gov/license/

Simmler Inc / initiated 2002-12-12 / Terminated / root cause: labeling and UDI

FDA source

Simmler Inc began a recall of 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... on 2002-12-12. The reason FDA records is "Fixing solution bottles are labeled as buffering solution". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0653-03
Status: Terminated
Initiated: 2002-12-12
Posted: 2003-03-20
Terminated: 2004-08-16
Recalling firm: Simmler Inc
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.
Reason for recall: Fixing solution bottles are labeled as buffering solution.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Lot #92558, Exp. March, 2004

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)