CLASS II Device recall · Reported 18 Sep 2019 · FDA Enforcement Report

Rotem ex-tem Rest of the world recalled by Instrumentation Laboratory

Instrumentation Laboratory is recalling Rotem ex-tem Rest of the world, distributed in Illinois, Michigan, Wisconsin. The recall was initiated on 23 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # : 42255701

Quantity recalled722 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2487-2019
FDA event ID: 83523
Recalling firm: Instrumentation Laboratory, Bedford, MA
Classification: Class II
Status: Terminated
Recall initiated: 23 Jul 2019
FDA classified: 6 Sep 2019
Reported: 18 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Jul 2019	Recall initiated by company
6 Sep 2019	Classified by FDA	+45 days
18 Sep 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Prolonged clotting times

Product as listed by the FDA

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

Where it was distributed

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.

Illinois Michigan Wisconsin

Questions about this recall

Is Rotem ex-tem Rest of the world recalled?

Yes. Instrumentation Laboratory recalled Rotem ex-tem Rest of the world on 23 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2487-2019.

Why was it recalled?

Prolonged clotting times

Which lots are affected?

Lot # : 42255701

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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