IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE recall
IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics…
Why was IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE recalled?
Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
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?
Lots 260 through 275
- Product
- IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics…
- Recalling firm
- Siemens Healthcare Diagnostics
- Quantity
- 18,489 units
- Distribution
- Worldwide distribution.
- Recall date
- May 7, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)