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Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT recallZ-1946-2015 · Axis-Shield Diagnostics, Ltd. · initiated Mar 20, 2015

Class II Terminated All recalls posted in July 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Axis-Shield Diagnostics, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

Axis Shield sent an Urgent Field Safety Notice letter dated March 20, 2015 to their customers via email and written notice sent with confirmed delivery receipt. The letter identified the affected product, problem and actions to be taken. Recommended Action to Customer is as follows: Confirm receipt of FSN to Axis-Shield. Do not use the affected Reagent lots referenced in the safety notice. In the event of holding one of the affected lots, immediately contact Axis-Shield Product Support Department to arrange for replacement material and return any defective product to Axis-Shield. Complete reconciliation form. Complete acknowledgement of the safety notice within 10 working days. Ensure safety notice has been distributed and reviewed by all appropriate personnel within your organization. If further distribution of affected lots to another organization has been made, inform them of this Product Recall and provide a copy of this safety notice to them. Retain a copy of the safety notice for their records. For any issues or concerns contact Axis-Shield via e-mail; MDL-AXD-Product- [email protected].

Recall details

Recall number
Z-1946-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 20, 2015
Posted by the FDA
Jul 1, 2015
Recalling firm
Axis-Shield Diagnostics, Ltd.
Quantity
52 kits + 75 kits Beckman Coulter Brand OUS
Product code
LPS
FDA submissions
K083222
Distribution
Worldwide Distribution - US Nationwide in the states of: KY, WA, CA, and PA and the country of Germany.

Product description

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 Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.

Code information (models, lots, serial numbers)

Part Number/Lot Number: FHBC100/802899574; FHRWR100/802899249; FHRWR1000/802899248; FHRWR200/802899989; FHRWR200/802899250; FHRWCN1/802900104

Other devices under the same FDA submission

3 devices cleared under K083222 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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