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Terminated

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

FDA Recall Z-2159-2008 · Posted 2008-08-25

Recalling FirmThermoFisher Scientific Co., LLC
Recall StatusTerminated
Product CodeIFP
Date Initiated2008-05-01
Date Terminated2012-08-13
Product Quantity1052 x 4 liters, 564 x 20 liters

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%.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution --- including USA and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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