Reported Jul 11, 2018 · Terminated
VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
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 · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
- Lot codes and dates
- Lot Numbers
2616-0165-48662616-0165-49042616-0165-48702616-0165-48692616-0165-52662616-0165-53072616-0165-52332616-0165-52322616-0165-56112616-0165-56102616-0165-56482616-0165-56492616-0165-62182616-0165-62752616-0165-62202616-0165-62212616-0165-62192616-0165-62762616-0165-67912616-0165-68322616-0165-67922616-0165-67872616-0165-72252616-0165-72262616-0165-72232616-0165-72142616-0165-7222
- Lot Numbers
- Amount recalled
- 5712
Where it was sold
- Nationwide
Why it was recalled
There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.
This product could cause temporary or reversible health problems — stop using it.
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