Z-2944-2018Class II

Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a...

Name: Z-2944-2018 Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a...
Creator: Roche Diagnostics Corporation
Published: 2018-07-16
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2018-07-16 / Terminated

FDA source

Roche Diagnostics Corporation began a recall of 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... on 2018-07-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2944-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-16
Posted: 2018-08-27
Terminated: 2019-05-16
Recalling firm: Roche Diagnostics GmbH
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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: 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.
FDA 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 [email protected]. " 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 in commerce: 12 units
Distribution: US Distribution to states of: CA, NY,TX, WA, and WI.
Product codes and lots: All units

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2944-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2944-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-27

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)