Z-1094-03

Becton Dickinson's ProbeTec (tm) ET Instrument

Name: Z-1094-03 Becton Dickinson's ProbeTec (tm) ET Instrument
Creator: Becton Dickinson & Co.
Published: 2003-07-21
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2003-07-21 / Terminated

FDA source

Becton Dickinson & Co. began a recall of Becton Dickinson's ProbeTec (tm) ET Instrument on 2003-07-21. The reason FDA records is "Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1094-03
Status: Terminated
Initiated: 2003-07-21
Posted: 2003-08-20
Terminated: 2003-11-19
Recalling firm: Becton Dickinson & Co
Product: Becton Dickinson's ProbeTec (tm) ET Instrument
Product code: LSL Dna-Reagents, Neisseria
Reason for recall: Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.
FDA root cause: Other
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.
Quantity in commerce: 1015 units
Distribution: Product was distributed to domestic and military end users nationwide and international distributors.
Product codes and lots: Instrument serial numbers 1001-2056

Product code LSL

K984631Class IIBdprobetec Et Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified DNA AssayBecton Dickinson Microbiology Systems / cleared 1999-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)