PlainRecordsFDA · Medical device recall
enGen Track System with enGen Select v5.0 with autoverification… and 1 more product
- Date
- Feb. 19, 2014
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Ortho-Clinical Diagnostics
- Reason
- Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems.
- Distribution pattern
- Worldwide Distribution - USA Nationwide in the states and countries of: AZ, FL, WV, TX, PA, DE, MI, OH, TN, IL, NC, Chile, India, Italy, Portugal, Spain, Sweden, UK
2 products in this recall
enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry…
- Product
- enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.
- Quantity
- 8 units
- Codes and lots
- Autoverification and Custom Rules for enGen Laboratory Automation Systems using enGenTM Select v5.0
- Recall started
- Oct. 8, 2013
- Device type
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Root cause (FDA)
- Software design
- What the company told customers
- Ortho Clinical Diagnostics (OCD), issued an Urgent Product Correction Notification letter dated October 7, 2013 and on December 17, 2013 to their customers via Federal Express or via US Postal Service. The letter identified the affected product, problem and actions. The notices advise the customers to ensure that all required data elements are entered and in the correct format if using the autoverification or custom rules for the referenced enGen Laboratory Automation Systems. OCD trained service representatives will contact all affected customers. Customers with questions may call the Customer Technical Service at 1-800-421-3311.
- Recall number
- Z-0941-2014
enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM…
- Product
- enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.
- Quantity
- 20 units
- Codes and lots
- Custom v3.2.2 & Below Configuration Files
- Recall started
- Oct. 8, 2013
- Device type
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Root cause (FDA)
- Software design
- What the company told customers
- Ortho Clinical Diagnostics (OCD), issued an Urgent Product Correction Notification letter dated October 7, 2013 and on December 17, 2013 to their customers via Federal Express or via US Postal Service. The letter identified the affected product, problem and actions. The notices advise the customers to ensure that all required data elements are entered and in the correct format if using the autoverification or custom rules for the referenced enGen Laboratory Automation Systems. OCD trained service representatives will contact all affected customers. Customers with questions may call the Customer Technical Service at 1-800-421-3311.
- Recall number
- Z-0942-2014
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0941-2014, Z-0942-2014. The agency record governs; check it and the company before acting.