Recall record at a glance
| Official record | Z-0045-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Completed |
| Recalling firm | Sysmex America, Inc. |
| Report date | Nov 1, 2017 |
| Recall initiation date | Sep 8, 2017 |
| Quantity | 23,239 units (9353 US) |
| Location | Lincolnshire, IL, United States |
Official product description
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
Why the product 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.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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