Reported Sep 21, 2016 · Terminated
Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the…
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?
- Fluorocell PLT reagent, Catalog #CD994563 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
11 of 11 products
Products covered by this recall # Product as published 1 Lot number A5053, Expiration date 12/21/2016 2 Lot number A5054, Expiration date 12/21/2016 3 Lot number A5041, Expiration date 9/2/2016 4 Lot number A5042, Expiration date 9/2/2016 5 Lot number A5044, Expiration date 10/2/2016 6 Lot number A5046, Expiration date 11/9/2016 7 Lot number A5047, Expiration date 11/17/2016 8 Lot number A5048, Expiration date 11/17/2016 9 Lot number A5049, Expiration date 11/26/2016 10 Lot number A5050, Expiration date 11/26/2016 11 Lot number A5055, Expiration date 12/24/2016 - Amount recalled
- 3868 units
Where it was sold
Why it was recalled
There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using the recalled lots may exhibit lower than expected PLT-F and IPF values. The issue may be recognized by a large discrepancy between the Impedance platelet (PLT-I) value and a false low PLT-F value. In most cases, the falsely decreased PLT-F results displayed a "PLT Abn Scattergram" message with asterisks beside the results indicating the data is unreliable. In rare instances, platelet flags may be absent. The PLT-I counts are unaffected. The PLT-F is a reflex test used to confirm PLT-I results due to flagging or low values. As such, the likely impact to patient results is low. Affected results display a discrepancy between the PLT-I and PLT-F, with lower than expected PLT-F results that do not match the patient's clinical picture.
This product could cause temporary or reversible health problems — stop using it.
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