FDA recall Z-0071-2026

Product

SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.

Reason for recall

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.

Distribution

US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico Singapore

Key facts

Status

Ongoing

Initiation date

2025-09-03

Report date

2025-10-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0071-2026