Recall Z-1790-2020 ยท NAO Test, Carbohydrate Deficient Transferrin
CSL Behring GmbH
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
| Date | Mar 2, 2020 |
| Status | Terminated |
| Reason | Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthcare Diagnostics issued Urgent Medical Device Correction (UMDC) letter PP-20-002.A.US to the 5 affected customers in the U.S. on March 5, 2020 via FedEx overnight delivery. ( Urgent Field Corrective Action (UFCA) PP20-002.A.OUS was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities). Letter states reason for recall, health risk, and action to take by the Customer Please review this letter with your Medical Director. Discontinue use of and discard the kit lots listed in Table 1. Revie |
| Quantity | 297 PCK US; 1247 PCK OUS |
| Distribution | IN, KS, MO, OH, VA Foreign: Australia, Austria, Bangladesh, Belgium, Canada, China Czech Republic, Egypt, Finland, France, Germany, Great Britain, Hungary India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Republic Korea, Russia Federation, Slovakia, Slovenia, South Africa, Spain Sw |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060677 | N LATEX CDT Dade Behring, Inc., Aug 25, 2006 |