VITROS 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VITROS Chemistry Products THC (Ca

FDA device recall Z-1167-2007 · posted 2007-08-16 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

Software design. The firm received a customer complaint regarding a qualitative positive THC (Cannabinoids) result obtained from a THC quality control fluid that was known to be negative when using VITROS Chemistry Products THC Reagent. A second customer complaint was received a month later. OCD's investigation concluded that under specific circumstances, incorrect qualitative results for Cannabi

Action taken

On 5/17/07, OCD informed its foreign affiliates of the field correction by e-mail, and instructed them to inform their customers who received the VITROS 5,1 FS Chemistry Systems as well as the VITROS Chemistry Products THC (Cannabinoids) and/or AMPH (Amphetamine) Reagents of this issue. On 5/18/07, all US OCD direct customers and end-use customers of consignees that received the VITROS 5,1 FS Chemistry Systems as well as the VITROS Chemistry Products THC (Cannabinoids) and/or AMPH (Amphetamine) Reagents, were informed of the "field correction" by US Postal Service letter, provided with a new Assay Data Disk (ADD #5465), and were instructed to load it and recalibrate these assays, if necessary.

Root cause

Other

Status

Terminated

Product code

JJE

Quantity affected

Domestic: 604, International: 598

Distribution

Nationwide and Worldwide

Date initiated

2007-05-17

Date posted

2007-08-16

Date terminated

2012-05-02

Location

Rochester, NY

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