Z-1167-2007

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

Name: Z-1167-2007 VITROS 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VITROS Chemistry...
Creator: Ortho-Clinical Diagnostics
Published: 2007-05-17
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2007-05-17 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VITROS Chemistry Products THC (Cannabinoids) or AMPH (Amphetamine)... on 2007-05-17. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1167-2007
Status: Terminated
Initiated: 2007-05-17
Posted: 2007-08-16
Terminated: 2012-05-02
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VITROS Chemistry Products THC (Cannabinoids) or AMPH (Amphetamine) Reagents, Cat. No. 680 1375.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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
Root cause tag: software
FDA root cause: Other
Action: 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.
Quantity in commerce: Domestic: 604, International: 598
Distribution: Nationwide and Worldwide
Product codes and lots: Software Version 2.2.1, Serial Numbers 34000121 to 34001377.

Product code JJE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)