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

FDA device recall Z-1946-2015 · posted 2015-07-01 · Terminated

Recall details

Recalling firm

Axis-Shield Diagnostics, Ltd.

Reason for recall

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

Action taken

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- Support@alere.com.

Root cause

Under Investigation by firm

Status

Terminated

Product code

LPS

Quantity affected

52 kits + 75 kits Beckman Coulter Brand OUS

Distribution

Worldwide Distribution - US Nationwide in the states of: KY, WA, CA, and PA and the country of Germany.

Date initiated

2015-03-20

Date posted

2015-07-01

Date terminated

2015-10-27

Location

Dundee, United Kingdom

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