FDA Medical Device Recalls (openFDA)
ThermoFisher Scientific Co., LLC: 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
- Recall number
- Z-2159-2008
- Recalling firm
- ThermoFisher Scientific Co., LLC
- 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
- Status
- Terminated
- Initiated
- 2008-05-01
- Posted
- 2008-08-25
- Terminated
- 2012-08-13
- Reason
- 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
- 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
- 1052 x 4 liters, 564 x 20 liters
- Distribution
- Worldwide Distribution --- including USA and Canada.
- Lot, serial or model codes
- Lot 075923
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IFP
- Firm FEI
- 2214740
- Firm city
- Fair Lawn
- 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