FDAClass IIMay 7, 2014

Alfa Wassermann Diagnostic Technologies recall

Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin…

Why was Alfa Wassermann Diagnostic Technologies recalled?

Extremely low absorbance readings.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

ACE¿ AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610)

Product
Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin…
Recalling firm
Alfa Wassermann, Inc.
Quantity
SA1047 lot F3609: 146; RX1047 lot F3610: 53
Distribution
US Nationwide Distribution
Recall date
May 7, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls