Recall Z-1004-2015— Ortho-Clinical Diagnostics
Class III · Terminated
Class III FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2014-09-29, terminated 2017-04-03. It names 2 FDA 510(k) clearances: K063144, K031924. Product: VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-quantitative, and qualitative measurement of analytes. Reason: Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2..
- Recalling firm
- Ortho-Clinical Diagnostics
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-09-29
- Terminated
- 2017-04-03
- Firm location
- Rochester, NY, United States
510(k) clearances named in this recall
2 on FDA's record- K063144 — VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
- K031924 — VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1
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 Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-quantitative, and qualitative measurement of analytes
Reason for recall
Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
Data sourced from openFDA. This site is unofficial and independent of the FDA.