Sysmex Fluorocell(R) PLT Fluorocell PLT is used to recall
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…
Why was Sysmex Fluorocell(R) PLT Fluorocell PLT is used to 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: A6051 A6052 A6053 A6054 A6055 A6056 A6057 A6058 A6059 A6060 A6061 A6062 A6063 A6064 A6065 A6066 A6067 A6068 A6069 A6070 A6071 A6072 A6073 A6074 A6075 A6076 A6077 A6078 A6079 A6080 A6081 A6082 A6083 A6084 A6085 A6086 A6087 A6088 A6089 A6090
- Product
- 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…
- Recalling firm
- Sysmex America, Inc.
- Quantity
- 23,239 units (9353 US)
- Distribution
- Worldwide Distribution - US (nationwide including Puerto Rico) Internationally to New Zealand, Brazil, India, Philippines, Nicaragua, Argentina, Australia, Chile, Viet Nam, Colombia, Pakistan, Malaysia, Dubai, Germany, Hong Kong, Bangladesh, Uruguay Thailand, China, Saudi Arabia, Taiwan, Honduras, Ecuador, Kuwait, South Korea, and Costa Rica
- Recall date
- November 1, 2017
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)