Sysmex XE-2100 Automated Hematology System recall
Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C.…
Why was Sysmex XE-2100 Automated Hematology System recalled?
There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.
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?
catalog #983-1341-1, all serial numbers
- Product
- Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C.…
- Recalling firm
- Sysmex America, Inc.
- Quantity
- 1,099 units
- Distribution
- Nationwide distribution: USA including Puerto Rico.
- Recall date
- November 14, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)