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Terminated

Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides and VITROS Chemistry Products MicroTip Reagents.

FDA Recall Z-1521-2015 · Posted 2015-04-25

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeJJE
Date Initiated2015-03-10
Date Terminated2018-06-01
Product QuantityVITROS 5.1 System: Domestic - 909; Foreign - 1250; 5,1 Refurbished: Domestic - 66 units, Foreign - 152

Reason for Recall

Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. If this anomaly occurred previously, an indication would be a series of results that were similar across multiple samples (i.e., results could be believable or outside of the Reportable Range for the intended assay).

Firm Action

On 3/10/2015, URGENT PRODUCT CORRECTION NOTIFICATION letters (Ref. CL2015-047, dated 3/10/2015) were sent to users notifying them of the issue and advising them of the required actions. Customers are to complete and return the Confirmation of Receipt no later than March 23, 2015. The firm is currently working on a resolution and will issue a follow up notification upon the software's availability. For questions, please contact Customer Technical Services at 1-800-421-3311.

Root Cause

Software in the Use Environment

Distribution Pattern

Worldwide Distribution -- USA, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063144VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEMOrtho-Clinical Diagnostics, Inc. · 2006-11-13K031924VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1Ortho-Clinical Diagnostics · 2003-08-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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