Immulite ¿ 2000/immulite ¿ 2000 Xpi Folic Acid recall
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid
Why was Immulite ¿ 2000/immulite ¿ 2000 Xpi Folic Acid recalled?
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
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?
Folic Acid, Folic Acid (IMMULITE 2000/IMMULITE 2000 XPi L2KFO2, L2KFO6) Lot codes: Folic Acid Lot # 502 503 504 505 506 508 514
- Product
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- N/A
- Distribution
- Nationwide and Canada, Mexico, and Thailand
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)