Reported May 7, 2014 · Terminated
Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST 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 AST Reagent
- Product UsageFor quantitative determination of AST 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 laboratories
- Lot codes and dates
- ACE¿ AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610)
- Amount recalled
- SA1047 lot F3609: 146; RX1047 lot F3610: 53
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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