VITROS Chemistry Products --- ALT Slides --- [REF] 165 5281 --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester

FDA device recall Z-1277-2012 · posted 2012-03-22 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

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).

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

JIX

Quantity affected

4306

Distribution

Worldwide Distribution - USA (nationwide)

Date initiated

2012-02-02

Date posted

2012-03-22

Location

Rochester, NY

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