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

Becton Dickinson's ProbeTec (tm) ET Instrument

FDA Recall Z-1094-03 · Posted 2003-08-20

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeLSL
Date Initiated2003-07-21
Date Terminated2003-11-19
Product Quantity1015 units

Reason for Recall

Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.

Firm Action

The recalling firm notified consignees by letter on 7/21/2003 and advised of the potential for incorrect optical bundle installation. The firm provided an optical test procedure with materials to conduct an on site performance test. Consignees were instructed not to report patient results until optical performance has been verified. Firm will replace or repair failing instruments.

Root Cause

Other

Distribution Pattern

Product was distributed to domestic and military end users nationwide and international distributors.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984631BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAYBecton Dickinson Microbiology Systems · 1999-11-04

Official Source

View FDA Recall →

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

↑