Recall Z-3118-2017 ยท LDP Colorimetry, Acetaminophen
Beckman Coulter Inc.
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
| Date | Jul 20, 2017 |
| Status | Terminated |
| Reason | Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued letters dated 7/17/2017 via regular mail and email on 7/20/2017 to all customers receiving the affected product. |
| Quantity | 320 units |
| Distribution | Distribution US nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081938 | ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 Genzyme Diagnostics P.E.I., Inc., May 1, 2009 |