Z-0302-2017Class II

ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the...

Name: Z-0302-2017 ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the...
Creator: TEM Systems Inc
Published: 2016-09-13
License: https://open.fda.gov/license/

TEM Systems Inc / initiated 2016-09-13 / Terminated / root cause: manufacturing process

FDA source

TEM Systems Inc began a recall of ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in... on 2016-09-13. FDA classified it as Class II and gives the reason as "Customers complained of low/empty reagent vials". 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-0302-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-13
Posted: 2016-10-23
Terminated: 2017-12-05
Recalling firm: TEM Systems Inc
Product: ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Customers complained of low/empty reagent vials.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customers were notified of the recall by an Urgent Important Customer Information letter on 9/13/2016. The letter described the device and the problem. Customers were told to stop using the product and to call for replacement product. The letter included a Confirmation of Compliance Letter which was to be completed and returned.
Quantity in commerce: 637 boxes x 10 vials
Distribution: Nationwide Distribution -- AR, CA, DC, GA, HI, ID, IL, IN, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV.
Product codes and lots: Lot No. 21929007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0302-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0302-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-23

Product code JPA

K101533Class IIEx-Tem. Fib-Tem, and Ap-Tem for Rotem Delta Thromboelastometry SystemTem Innovations GmbH / cleared 2011-08-10

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)