Z-1927-2019Class III

cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval

Name: Z-1927-2019 cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval
Creator: Roche Diagnostics Corporation
Published: 2019-04-04
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2019-04-04 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Corporation began a recall of cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval on 2019-04-04. FDA classified it as Class III and gives the reason as "There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1927-2019
Classification: Class III
Status: Terminated
Initiated: 2019-04-04
Posted: 2019-07-03
Terminated: 2020-05-12
Recalling firm: Roche Diagnostics GmbH
Product: cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
Root cause tag: manufacturing process
FDA 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 in commerce: 4 units
Distribution: US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA
Product codes and lots: Serial Numbers - 1001 through 1044

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1927-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1927-2019	Class III	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-02
Z-1928-2019	Class III	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-02

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)