Z-2303-2008

Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff...

Name: Z-2303-2008 Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff...
Creator: EMD Chemicals Inc
Published: 2008-06-02
License: https://open.fda.gov/license/

EMD Millipore Corporation / initiated 2008-06-02 / Terminated / root cause: manufacturing process

FDA source

EMD Chemicals Inc began a recall of Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff Reagent 225 mL, Light Green SF Yellowish Stain 225 mL... on 2008-06-02. The reason FDA records is "Two complaints that kit was not performing properly with positive controls". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2303-2008
Status: Terminated
Initiated: 2008-06-02
Posted: 2008-09-20
Terminated: 2008-09-22
Recalling firm: EMD Millipore Corporation
Product: Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff Reagent 225 mL, Light Green SF Yellowish Stain 225 mL, Sodium Carbonate Solution 225 mL and Periodic Acid Solution 225 mL' EMD Chemicals, Inc. 480 S. Democrat Road, Gibbstown, NJ 08027 Each kit provides reagents sufficient for a maximum of 100 tests.
Product code: HZT Reagent, Schiff
Reason for recall: Two complaints that kit was not performing properly with positive controls.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Distributors were notified of the recall on June 4, 2008 by e-mail, followed by a letter. The letter dated June 4, 2008, describes the problem, instructs customers to discontinue use of the product and contact EMD Chemicals for product replacement. An Important Product Recall form was also included in each letter, asking that the form be completed and returned to EMD. Contact EMD Chemicals Technical Service Department at 1-800-222-0342.A
Quantity in commerce: 29 kits
Distribution: Nationwide.
Product codes and lots: Item number 64945/93; Lot # 8055, Exp. August 31, 2009.

Product code HZT

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)