Z-1379-2015Class II

ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH

Name: Z-1379-2015 ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH
Creator: TEM Systems Inc
Published: 2014-10-23
License: https://open.fda.gov/license/

TEM Systems Inc / initiated 2014-10-23 / Terminated / root cause: manufacturing process

FDA source

TEM Systems Inc began a recall of ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH on 2014-10-23. FDA classified it as Class II and gives the reason as "Some of vials were found to be partially filled". 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-1379-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-23
Posted: 2015-04-03
Terminated: 2015-08-13
Recalling firm: TEM Systems Inc
Product: ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Some of vials were found to be partially filled.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Tem sent an Dear Customer letter dated October 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You are entitled to return products delivered to you in the event that they are defective or otherwise not in conformity with your order when you received them. If you observe a low level of diluent in a box of Rotrol P lot number 41819801 at your location, please contact us for a free of charge replacement box from a new lot of Rotrol P. You can reach us at: Email: [email protected] Phone: 919-941-7777, Option 2 Toll Free: 1-866-597-1652, Option 2 We apologize for any inconvenience you may experience.
Quantity in commerce: Total 1574 x 5 vials per box
Distribution: Nationwide Distribution
Product codes and lots: Article number 503-25 (US ROTROL P), Lot no. 41819801, exp date 2016-11 and Lot no. 41855701, exp date 2017-06.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1379-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1379-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-03

Product code JPA

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)