Recall Z-1311-2018 ยท PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
Roche Diagnostics Corporation
Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
| Date | Dec 22, 2017 |
| Status | Terminated |
| Reason | Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers. |
| Root cause | Software design |
| Action | The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated December 22, 2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " Immediately discontinue use of Elecsys BRAHMS PCT (catalog number 07301715190) reagent lot number 204084 on the cobas e 801 module. " Discard affected product according to local guidelines. " Complete the attached fax form and fax it to 1-800-722-7222. " File this Urgent Medical Device Removal (UMDR) for future reference. Please contact the Roche Support Network Customer |
| Quantity | 47 |
| Distribution | US Distribution in states of: CA, FL and IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160729 | Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 Roche Diagnostics, Jun 13, 2016 |