Z-2066-2012Class II

VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative...

Name: Z-2066-2012 VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative...
Creator: Ortho-Clinical Diagnostics
Published: 2012-05-21
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2012-05-21 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest on 2012-05-21. FDA classified it as Class II and gives the reason as "software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment". 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-2066-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-21
Posted: 2012-07-23
Terminated: 2018-07-05
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.
Root cause tag: software
FDA root cause: Software design
Action: Ortho Clinical Diagnostics notified its foreign direct account consignees via email on May 21, 2012 and their direct account US consignees were sent an Urgent Distributor Safety Notice on May 22, 2012 via US Postal Service Priority Letter. The recall letter notified the consignees of the situation and that Ortho will replace their remaining inventory of non-expired GENs 14 or 15 for VITROS VALP Reagent only. Until then the consignees can continue using the VITROS VALP Reagent, GENs 14 or 15 until the replacement arrives. And to note that VITROS VANC Reagent, GENs 19 &20 are now expired. --- The letter also requested the consignees to complete and return the enclosed Confirmation of Receipt, no later than May 31, 2012. And to review the quality control beginning with the Calibration date of the VITROS VANC Reagent ( GEN 21 or above) or VITROS VALP (GEN & above) so that the QC results can be verified to be within acceptable ranges. --- For customers using VITROS VALP Reagent GEN 14 or 15, they were to respond as to the quantity of the non-expired GENs 14 and 15 remaining inventory; to load and use only one GEN of VITROS VALP Reagent at a time on the system until the replacement arrives. This notification letter should be posted by each VITROS System using the VITROS VALP Reagent or VITROS VANC Reagent or with the user documentation. And in addition, if these products were distributed then this information should be forwarded as well. For questions regarding this recall call 585-453-4110.
Quantity in commerce: 2044
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal.
Product codes and lots: Version 2.6.1 & Below

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2066-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2066-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-23
Z-2067-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-23
Z-2068-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-23

Product code JJE

K031924Class IIVitros 5,1 Fs Chemistry System, Vitros Chemistry Products Dhdl Reagent Pack, Calibrator Kit 19, Fs Calibrator 1Ortho-Clinical Diagnostics / cleared 2003-08-07

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)