United StatesSYNCHRON Systems Phosphorus (PHOSm) Reagent, REF 467868 (UDI 15099590233358) — lots M309642, M309641, M401490, M404365, M406380, M406417, M408408, M410466, M410513, M412278 — sold in multiple U.S. states and in Canada, Mexico and Singapore, is affected. Specific lots may fail calibration before the lot expiration date, which can cause delayed patient results.
What's being recalled
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Recalling firm: Beckman Coulter Inc., Brea, CA, United States.
How to identify it
UDI: 15099590233358/ Lot Numbers: M309642 M309641 M401490 M404365 M406380 M406417 M408408 M410466 M410513 M412278
The hazard
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico Singapore
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)