Recalls / —
—#131547
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.
- FDA product code
- CDT — Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K812029
- Affected lot / code info
- Lot 0704-3318-4774 (expiry date 01 Dec 2015)
Why it was recalled
Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Ortho-Clinical Diagnostics
- Address
- 513 Technology Blvd, Rochester, New York 14626-3601
Distribution
- 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.
Timeline
- Recall initiated
- 2014-11-06
- Posted by FDA
- 2014-12-22
- Terminated
- 2017-02-28
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #131547. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.