IMMULITE /IMMULITE 1000 Systems TIE Total IgE recall
IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic…
Why was IMMULITE /IMMULITE 1000 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 326 through 333
- Product
- IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic…
- Recalling firm
- Siemens Healthcare Diagnostics
- Quantity
- 5953 units
- Distribution
- Worldwide distribution.
- Recall date
- May 7, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)