Z-1090-2016Class II

ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control...

Name: Z-1090-2016 ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control...
Creator: TEM Systems Inc
Published: 2016-02-18
License: https://open.fda.gov/license/

TEM Systems Inc / initiated 2016-02-18 / Terminated / root cause: manufacturing process

FDA source

TEM Systems Inc began a recall of ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of... on 2016-02-18. FDA classified it as Class II and gives the reason as "Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 2016". 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-1090-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-18
Posted: 2016-03-09
Terminated: 2016-06-30
Recalling firm: TEM Systems Inc
Product: ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.
Product code: GGN Plasma, Coagulation Control
Reason for recall: Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 2016.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent Important Customer Information notice was sent to accounts on 2/17/2016. The notice requested that they discontinue use of the product and to contact them for a replacement. The letter also included a response form to be returned.
Quantity in commerce: 476 boxes x 5 vials
Distribution: Distributed in the states of AZ, AR, CA, FL, GA, HI, ID, IL, IN, LA, MD, MA, MN, MO, NE, NJ, NM, NY, PA, OH, SC, SD, TN, TX, UT, WA, WV and the country of Germany.
Product codes and lots: Lot 41925401

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1090-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1090-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-09

Product code GGN

K083842Class IIRotem Delta Thromboelastometry SystemPentapharm GmbH / cleared 2010-03-23

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)