Reported Sep 18, 2019 · Terminated
ROTEM ex-tem; US Part No: 503-05-US
Instrumentation Laboratory Co.
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: Instrumentation Laboratory Co. · 180 Hartwell Rd · Bedford, MA · 01730-2443
Is this the product you have?
- ROTEM ex-tem
- US Part No503-05-US
- Lot codes and dates
- Lot # 42255901 (United States)
- Amount recalled
- 364 kits
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Prolonged clotting times
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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