Recall Z-2139-2014— Ortho-Clinical Diagnostics

Name: FDA recall Z-2139-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-07

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2014-07-07, terminated 2018-05-21. It names one FDA 510(k) clearance: K083173. Product: VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID).. Reason: Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2014-07-07
Terminated: 2018-05-21
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K083173 — VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEMOrtho-Clinical Diagnostics·cleared 2008-12-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID).

Reason for recall

Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.

Data sourced from openFDA. This site is unofficial and independent of the FDA.