Reported May 7, 2014 · Terminated
Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in…
Alfa Wassermann, 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: Alfa Wassermann, Inc. · 4 Henderson Dr · West Caldwell, NJ · 07006-6608
Is this the product you have?
- Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent
- Product UsageFor quantitative determination of ALT in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office labs
- Lot codes and dates
- ACE¿ ALT Reagent (Product reorder number SA1046 Lot F3604)
- Amount recalled
- 731 Kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Extremely low absorbance readings.
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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