Reported Jul 8, 2015 · Terminated

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and…

Axis-Shield Diagnostics, Ltd.

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: Axis-Shield Diagnostics, Ltd. · The Technology Park · Dundee · N/A

Is this the product you have?

  • Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format
  • and Private Label(Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480
  • AU680 and AU5800)) Product UsageFor in-vitro quantitative determination of total homocysteine in human plasma or serum
Lot codes and dates

6 of 6 products · 6 lot codes

Recalled lot codes, grouped by product number
Part NumberLot Number
FHBC100
  • 802899574
FHRWR100
  • 802899249
FHRWR1000
  • 802899248
FHRWR200
  • 802899989
FHRWR200
  • 802899250
FHRWCN1
  • 802900104
Amount recalled
52 kits + 75 kits Beckman Coulter Brand OUS

Where it was sold

Why it was recalled

Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 27, 2015 · Data as of Sep 19, 5:26 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.