FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corporation: cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
- Recall number
- Z-1928-2019
- Recalling firm
- Roche Diagnostics Corporation
- Product
- cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
- Status
- Terminated
- Initiated
- 2019-04-04
- Posted
- 2019-07-03
- Terminated
- 2020-05-12
- Reason
- There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
- Root cause
- Nonconforming Material/Component
- Action
- On April 4, 2019, Roche issued Urgent Medical Device Correction notices (UMDC TP-00620) to customers via UPS Ground (receipt required). Customers were advised to take the following actions: 1) Inspect the tray input flap on the cobas p 501 or p 701 post-analytical unit to determine if it is loose. If it is not fastened securely or becomes loose prior to the part being replaced, contact your Roche Field Engineer Specialist (FES) to repair the instrument. 2) Complete and return the fax form (TP-00621) via fax or email 3) File the UMDC for future reference. Customers with questions may contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in the UMDC.
- Quantity
- 9 units
- Distribution
- US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA
- Lot, serial or model codes
- Serial Numbers - 1001 through 1037, and 502
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- 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