Z-2487-2019Class II

ROTEM ex-tem Rest of the world part No: 503-05 (ROW)

Name: Z-2487-2019 ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
Creator: Instrumentation Laboratory Co.
Published: 2019-07-23
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2019-07-23 / Terminated / root cause: manufacturing process

FDA source

Instrumentation Laboratory Co. began a recall of ROTEM ex-tem Rest of the world part No: 503-05 (ROW) on 2019-07-23. FDA classified it as Class II and gives the reason as "Prolonged clotting times". 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-2487-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-23
Posted: 2019-09-06
Terminated: 2020-04-27
Recalling firm: Instrumentation Laboratory Co.
Product: ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Prolonged clotting times
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: -Check your inventory for Lot No. 42255901 / 42255801 and destroy all remaining material. - Document the destruction on the Mandatory Tracking Response Record and return the completed and signed form to the fax number or e-mail address listed on the next page. -Contact your local representative for an alternative product lot of ROTEM ex-tem, Part No. 503-05-US / 503-05-CA. -Share this information with your laboratory staff and follow your internal procedures. -Forward this notification to all affected locations within your facility. -Retain a copy of this notification for your records. -Return the completed and signed form confirming lot destruction and quantities to: FAX No. 781-861-4207 or Email: [email protected] For Technical Questions: Call ROTEM PBM Technical Support Center at 1-800-678-0710, Option # 4 For Replacement Lot: Call IL Customer Service Center at 1-800-955-9525, Option # 0
Quantity in commerce: 722 kits
Distribution: States: IL WI MI Canada, Spain, Portugal, Poland, Italy, Israel, Switzerland, Denmark, Kazakhstan, United Kingdom, Germany, Netherlands, Belgium, France, Jordan, India, Hong Kong, Austria, Czechia, Australia, Sri Lanka, Argentina, Vietnam, Singapore, Japan, South Korea, Cyprus, Ireland, Hungary, Sweden, Serbia.
Product codes and lots: Lot # : 42255701

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2487-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2485-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-06
Z-2486-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-06
Z-2487-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-06

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)