FDA Medical Device Recalls (openFDA)
Hologic, Inc.: Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
- Recall number
- Z-0676-2018
- Recalling firm
- Hologic, Inc.
- Product
- Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
- Status
- Terminated
- Initiated
- 2017-11-29
- Posted
- not on file
- Terminated
- 2018-08-22
- Reason
- 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.
- Root cause
- Mixed-up of materials/components
- Action
- Hologic initiated the recall on Wednesday, November 29, 2017. The method of notification was via overnight FedEx.
- Quantity
- 165 kits
- Distribution
- United States (US), Guam (GU), Japan (JP)
- Lot, serial or model codes
- K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, E7082
- 510(k) numbers
- not on file
- PMA numbers
- ["P920048"]
- Product code
- LKV
- Firm FEI
- 2024800
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28