FDAClass IIFebruary 28, 2018

Rapid for the TLiIQ(R) System recall

Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q

Why was Rapid for the TLiIQ(R) System recalled?

Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX.

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?

E7058

Product
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
Recalling firm
Hologic, Inc.
Quantity
N/A
Distribution
United States (US), Guam (GU), Japan (JP)
Recall date
February 28, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls