Reported Nov 1, 2017 · Completed
Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of…
Sysmex America, Inc.
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: Sysmex America, Inc. · 577 Aptakisic Rd · Lincolnshire, IL · 60069-4325
Is this the product you have?
- Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
- Lot codes and dates
- Lot Numbers
A6051A6052A6053A6054A6055A6056A6057A6058A6059A6060A6061A6062A6063A6064A6065A6066A6067A6068A6069A6070A6071A6072A6073A6074A6075A6076A6077A6078A6079A6080A6081A6082A6083A6084A6085A6086A6087A6088A6089A6090
- Lot Numbers
- Amount recalled
- 23,239 units (9353 US)
Where it was sold
- Nationwide
- PR
Why it was recalled
There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results obtained using the lots listed above may exhibit lower than actual PLT-F and IPF values. The issue may be recognized by a large discrepancy between the impedance platelet (PLT-I) result and the PLT-F result. In most cases, the falsely decreased PLT-F results display a PLT Abn Scattergram message with an asterisk beside the result or an Action Message: Difference between PLT and PLT- F. Check the results. These are indicators of unreliable data. In rare instances, platelet flags may be absent. The PLT-I results are unaffected.
This product could cause temporary or reversible health problems — stop using it.
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