VITROS CHEMISTRY PRODUCTS TRIG Slides…

Date

Dec. 31, 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

Product

VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Reason

Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.

Quantity

USA: 380 units, Foreign: 155 units

Codes and lots

Lot 0704-3318-4774 (expiry date 01 Dec 2015)

Recall started

Nov. 6, 2014

Device type

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Root cause (FDA)

Nonconforming Material/Component

What the company told customers

Ortho Clinical Diagnostics sent an Urgent Product Correction Notification dated November 6, 2014, via FedEx overnight courierand/or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all affected customers. The letter identified the product, the problem, and the acton to be taken by the customer. The letter informed the customers of the issue and advise them to discontinue use of the affected lot and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. For additional questions, please contact OCD's Customer Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.

Recall number

Z-0848-2015

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0848-2015. The agency record governs; check it and the company before acting.