FDA Medical Device Recalls (openFDA)
Simmler Inc: 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 number
- Z-0653-03
- 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.
- Status
- Terminated
- Initiated
- 2002-12-12
- Posted
- 2003-03-20
- Terminated
- 2004-08-16
- Reason
- Fixing solution bottles are labeled as buffering solution.
- 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
- 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.
- Lot, serial or model codes
- Lot #92558, Exp. March, 2004
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1950226
- Firm city
- St Louis
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28