Immulite ¿ 2000/immulite ¿ 2000 Xpi TG recall
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG
Why was Immulite ¿ 2000/immulite ¿ 2000 Xpi TG 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?
TG, TG (IMMULITE/IMMULITE 1000, LKTY1(D)), (IMMULITE 2000/IMMULITE 2000 XPi, LKTY2(D)) Lot codes: TG Lot # 346 347 348 349 350 351 352 353 354 355 356 D348 D349 D350 D351 D352 D353 D354 D356
- Product
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG
- 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)