Z-2159-2008

10% Buffered Formalin Phosphate; Certified For laboratory and manufacturing use only, not for drug, food or...

Name: Z-2159-2008 10% Buffered Formalin Phosphate; Certified For laboratory and manufacturing use only, not for drug, food or...
Creator: ThermoFisher Scientific Co., LLC
Published: 2008-05-01
License: https://open.fda.gov/license/

Thermofisher Scientific Oy / initiated 2008-05-01 / Terminated / root cause: manufacturing process

FDA source

ThermoFisher Scientific Co., LLC began a recall of 10% Buffered Formalin Phosphate; Certified For laboratory and manufacturing use only, not for drug, food or household use. Do not Transfer to an unmarked... on 2008-05-01. The reason FDA records is "Assay tests on retention sample of 10% Buffered Formalin Phosphate showed it to be 3.417%, which is below the specification of 4-5%". 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-2159-2008
Status: Terminated
Initiated: 2008-05-01
Posted: 2008-08-25
Terminated: 2012-08-13
Recalling firm: Thermofisher Scientific Oy
Product: 10% Buffered Formalin Phosphate; Certified For laboratory and manufacturing use only, not for drug, food or household use. Do not Transfer to an unmarked container. Catalog numbers: SF100-4, SF100-20 Fisher Scientific, Fail Lawn, NJ 07410
Product code: IFP Formalin, Neutral Buffered
Reason for recall: Assay tests on retention sample of 10% Buffered Formalin Phosphate showed it to be 3.417%, which is below the specification of 4-5%.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Urgent: Product Recall notification letters were sent by US mail on May 1, 2008. The letters asked that those in receipt of the product check their stock for this product, destroy any of the material that remains from the referenced lot, and then contact their local customer service center for a replacement. The letter also states that the appropriate corrective measures have already been instituted to prevent a recurrence.
Quantity in commerce: 1052 x 4 liters, 564 x 20 liters
Distribution: Worldwide Distribution --- including USA and Canada.
Product codes and lots: Lot 075923

Product code IFP

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)