FDAClass IIJune 3, 2015

Accessory Kit recall

Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent…

Why was Accessory Kit recalled?

The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.

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?

Accessory Kit - Product Code/Catalog #'s 10282965, 10373217 and 10286080

Product
Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent…
Recalling firm
Siemens Medical Solutions Diagnostics
Quantity
962 bottles
Distribution
Worldwide Distribution.
Recall date
June 3, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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