ROTROL P Control for ROTEM delta Thromboelastometry System… recallZ-1379-2015 · TEM Systems Inc · initiated Oct 23, 2014
Class II Terminated All recalls posted in April 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from TEM Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some of vials were found to be partially filled.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1379-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 23, 2014
- Posted by the FDA
- Apr 3, 2015
- Recalling firm
- TEM Systems Inc
- Quantity
- Total 1574 x 5 vials per box
- Product code
- JPA
- FDA submissions
- K083842, K101533
- Distribution
- Nationwide Distribution
Product description
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Code information (models, lots, serial numbers)
Article number 503-25 (US ROTROL P), Lot no. 41819801, exp date 2016-11 and Lot no. 41855701, exp date 2017-06.
Other devices under the same FDA submission
2 devices cleared under K083842, K101533 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ROTEM® delta SystemTem Innovations GmbH · System, Multipurpose For In Vitro Coagulation Studies4 reports
- ROTEM® ex-tem®Tem Innovations GmbH · System, Multipurpose For In Vitro Coagulation Studies1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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