Z-1946-2015Class II

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

Name: Z-1946-2015 Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test...
Creator: Axis-Shield Diagnostics, Ltd.
Published: 2015-03-20
License: https://open.fda.gov/license/

Axis-Shield Diagnostics, Ltd. / initiated 2015-03-20 / Terminated

FDA source

Axis-Shield Diagnostics, Ltd. began a recall of 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... on 2015-03-20. FDA classified it as Class II and gives the reason as "Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1946-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-20
Posted: 2015-07-01
Terminated: 2015-10-27
Recalling firm: Axis-Shield Diagnostics, Ltd.
Product: 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.
Product code: LPS Urinary Homocystine (Nonquantitative) Test System
Reason for recall: Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 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.
Product codes and lots: Part Number/Lot Number: FHBC100/802899574; FHRWR100/802899249; FHRWR1000/802899248; FHRWR200/802899989; FHRWR200/802899250; FHRWCN1/802900104

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1946-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1946-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02

Product code LPS

K083222Class IIAxis-Shield Liquid Stable (Ls) 2-Part Homocysteine Reagent, Model Fhrk100Axis-Shield Diagnostics, Ltd. / cleared 2009-07-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)