Z-0305-2007

Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set...

Name: Z-0305-2007 Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set...
Creator: EMD Chemicals Inc
Published: 2006-07-25
License: https://open.fda.gov/license/

EMD Millipore Corporation / initiated 2006-07-25 / Terminated

FDA source

EMD Chemicals Inc began a recall of Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light... on 2006-07-25. The reason FDA records is "Due to loose caps, the SO2 levels dropped significantly from release levels causing the product not to perform properly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0305-2007
Status: Terminated
Initiated: 2006-07-25
Posted: 2006-12-27
Terminated: 2008-10-06
Recalling firm: EMD Millipore Corporation
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.
Product code: KKS Acid, Periodic
Reason for recall: Due to loose caps, the SO2 levels dropped significantly from release levels causing the product not to perform properly.
FDA 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 in commerce: 74 kits
Distribution: Nationwide.
Product codes and lots: Item Number 64945/93 Lot # 5341, Exp. Date: May 31, 2007.

Product code KKS

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)