Recall Z-1946-2015 ยท LPS Urinary Homocystine (Nonquantitative) Test System
Axis-Shield Diagnostics, Ltd.
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.
| Date | Jul 1, 2015 (initiated Mar 20, 2015) |
| Status | Terminated |
| Reason | Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 Axis-Shield Diagnostics, Ltd., Jul 31, 2009 |