Recall Z-1280-2024 ยท GGT Assay, Erythropoietin
Siemens Healthcare Diagnostics, Inc.
Atellica IM Erythropoietin (EPO) Assay (100 Test)
| Date | Mar 11, 2024 (initiated Jan 24, 2024) |
| Status | Open, Classified |
| Reason | Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction notification letter dated 01/24/24 was sent to customers. Actions to be Taken by the Customer: Discontinue use of and discard the EPO kit lots listed in Table 1. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. For continued EPO patient testing in your laboratory during this time, please contact your Siemens representative to discuss alternat |
| Quantity | 1,057 units (46 US, 1,011 OUS) |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, CA, IA, IL, MI, MN, NC, NE, NV, NY, OH and TX; The countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Italy, Japan, Latvia, Mala |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183088 | ADVIA Centaur Erythropoietin (EPO) assay Axis-Shield Diagnostics Limited, Aug 2, 2019 |