—#107462

Product

VITROS Chemistry Products --- ALT Slides --- [REF] 165 5281 --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA. The recalled device is the calibration disk contained within the VITROS Calibrator Kit 3. The is can be identified with the label "VITROS Chemist y Systems --- Universal Calibration Diskette --- [REF] 871 6607 --- Ortho-Clinical Diagnostics" For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 3 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of AcP, ALT, ALKP, AMYL, AST, CK, GGT, LDH, and LIPA.

FDA product code: JIX — Calibrator, Multi-Analyte Mixture
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K001679, K922072
Affected lot / code info: Calibration Diskette (Product Code 8716607) and the Assay Data Diskette (Product Code 6801876), Data Release Version (DRV) 5653 through 5666 used in conjuction with of VITROS¿ Chemistry Products ALT Slides, Generation (GEN) 26 (Product Code 1655281).

Why it was recalled

Ortho Clinical Diagnostics received complaints of lower than expected results (< 6 U/L) for samples that were known to be outside of the measuring (reportable) range (> 1000 U/L) when using Calibration Diskette/Assay Data Diskette Data Release Version (DRV) 5653 through 5666 and VITROS Chemistry Products ALT Slides, Generation (GEN) 26 (Product Code 1655281).

Root cause (FDA determination)

Software design

Action the firm took

Ortho Clinical Diagnostic sent a Important Product Correction letter dated February 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed customers to: Install Calibration Diskette/Assay Data Diskette DRV 5667 on your VITROS System. Following a successful recalibration, you may resume using VITROS ALT Slides, GEN 26 remaining in your inventory. To please complete and return the Confirmation of Receipt form upon receipt of this notification. Please return this form no later than February 17, 2012. Post this notification by each VITROS System in your facility that utilizes the VITROS ALT Slides, or with the VITROS user documentation. Forward this notification if you have distributed this product outside of your facility. We apologize for the inconvenience this may have caused your facility. If you have any additional questions, please contact Customer Technical Services at 1-800-421-3311.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide)

Timeline

Recall initiated: 2012-02-02
Posted by FDA: 2012-03-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107462. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.