Reported Mar 16, 2016 · Terminated
ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material…
TEM Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TEM Systems Inc · 3210 E Nc Hwy 54 · Durham, NC · 27709
Is this the product you have?
- 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.
- Lot codes and dates
- Lot 41925401
- Amount recalled
- 476 boxes x 5 vials
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new TEM Systems Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.