Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).

FDA Recall Z-0935-04 · Posted 2004-07-20

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeKLT
Date Initiated2003-06-11
Date Terminated2004-05-10
Product Quantityunknown

Reason for Recall

Product was found to produce higher recoveries by about 7-12% compared to other lots.

Firm Action

Users were requested to discard and ask for replacement of the lot in question by letter.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K955644SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEMBeckman Instruments, Inc. · 1996-02-16

Official Source

View FDA Recall →

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

↑