FDAClass IIApril 9, 2014

Immulite 2000 recall

IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent…

Why was Immulite 2000 recalled?

There is a potential for incorrect results to be reported from processing of a sample tube.

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?

IMMULITE 2000: 10380062, 10380061,10380079, 10380065, 10360210, 10283632 IMMULITE 2000XPi: P010053/S007; 10373214 VersaCell: 10380063, 10389945, 10380064, 10287115, 10793839

Product
IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent…
Recalling firm
Siemens Medical Solutions Diagnostics
Quantity
1006 units
Distribution
Nationwide and Foreign Distribution.
Recall date
April 9, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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