FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corporation: Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for use with analyzers that perform tests in the area of clinical chemistry, immuno chemistry, coagulation, hematology, urinalysis, nucleic acid testing.
- Recall number
- Z-2944-2018
- Recalling firm
- Roche Diagnostics Corporation
- Product
- Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for use with analyzers that perform tests in the area of clinical chemistry, immuno chemistry, coagulation, hematology, urinalysis, nucleic acid testing.
- Status
- Terminated
- Initiated
- 2018-07-16
- Posted
- not on file
- Terminated
- 2019-05-16
- Reason
- Sample material may potentially come in contact with the pipetting nozzle during operation of cobas p 612 pre-analytical system (63x) (LCP1) with non-filter tips. The possible presence of biological material on the nozzle may cause contamination resulting in potential false positive results, depending on the sensitivity of the analytical technology.
- Root cause
- Under Investigation by firm
- Action
- The firm, Roche, issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated 7/6/18 to its customers on 7/6/18. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: Complete all sections of the enclosed faxback form and fax it to number 1-866-469-2231 or email it to Roche6840@stericycle.com. " Ensure you have at least a two-week supply of disposable filter tips before the Roche FES arrives to modify your system. " Provide copies of this Urgent Medical Device Correction (UMDC) to other clinicians who may need to be aware of this issue. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " File this UMDC for future reference. If you are using cobas p 612 pre-analytical (63x) (LCP1) systems for aliquoting in combination with non-filter tips, you must use filter tips until the root cause is identified and appropriate corrective actions have been implemented. Please 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 this UMDC.
- Quantity
- 12 units
- Distribution
- US Distribution to states of: CA, NY,TX, WA, and WI.
- Lot, serial or model codes
- All units
- 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