Recall Z-2159-2008 ยท IFP Formalin, Neutral Buffered
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
| Date | Aug 25, 2008 (initiated May 1, 2008) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.