Reported Feb 27, 2019 · Terminated
VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For…
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 · 1000 Lee Road · Rochester, NY · 14606
Is this the product you have?
- VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710
- INTENDED USEFor in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma
- Lot codes and dates
- Affected Lots/Expiry
25-5263 2017-09-0925-5503 2018-01-0625-5727 2018-04-3025-5974 2018-08-1425-6067 2018-11-0525-6393 2019-04-05 (only
- non expired lot) Unique Identifier10758750006748
- Affected Lots/Expiry
- Amount recalled
- 9014 Total (U.S. = 6798; OUS: U.S. = 2216)
Where it was sold
- Nationwide
Why it was recalled
Negative bias results when using VITROS VALP Reagent, GEN 25.
This product could cause temporary or reversible health problems — stop using it.
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