Reported Dec 31, 2014 · Terminated
VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products…
Ortho-Clinical Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics · 513 Technology Blvd · Rochester, NY · 14626-3601
Is this the product you have?
- 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.
- Lot codes and dates
- Lot 0704-3318-4774 (expiry date 01 Dec 2015)
- Amount recalled
- USA: 380 units, Foreign: 155 units
Where it was sold
- Nationwide
- PR
Why it was recalled
Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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