FDA Medical Device Recalls (openFDA)
EMD Chemicals Inc: Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests.
- Recall number
- Z-0305-2007
- Recalling firm
- EMD Chemicals Inc
- Product
- Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests.
- Status
- Terminated
- Initiated
- 2006-07-25
- Posted
- 2006-12-27
- Terminated
- 2008-10-06
- Reason
- Due to loose caps, the SO2 levels dropped significantly from release levels causing the product not to perform properly.
- Root cause
- Other
- Action
- On July 27, 2006 EMD contacted its direct account customers via letter. The firm requested discontinue use of the product and contact EMD for return.
- Quantity
- 74 kits
- Distribution
- Nationwide.
- Lot, serial or model codes
- Item Number 64945/93 Lot # 5341, Exp. Date: May 31, 2007.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KKS
- Firm FEI
- 2244894
- Firm city
- Gibbstown
- Firm state
- NJ
- 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