Reported Apr 2, 2014 · Terminated
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
AMS Diagnostics, LLC
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: AMS Diagnostics, LLC · 1790 N Commerce Pkwy · Weston, FL · 33326-3204
Is this the product you have?
- AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
- Lot codes and dates
- Model Numbers
400724014680146
- Lot codes
131083131084131085131086131087131088131089131081013108111310812131081313108141310815141081
- Model Numbers
- Amount recalled
- 116 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
Marketing the devices outside 510(k) requirements
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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