Recall Z-0884-2017 ยท MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Siemens Healthcare Diagnostics, Inc.
IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 X
| Date | Nov 18, 2016 |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use. |
| Root cause | Under Investigation by firm |
| Action | The firm, Siemens, sent an "Urgent Medical Device Correction Letter" (IMC 17-07.A.US, dated 11/2016) was sent via FedEx on 11/18/2016 to the US customers and an "Urgent Field Safety Notice" dated 11/2016 to customers outside the US (distribution is determined at the country level). The letter/notice described the product, problem and actions to be taken. Additionally, Field service personnel were sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. Customers were instructed to review letter with your medical doctor; review produc |
| Quantity | 4705 kits (US: 390 kits; OUS: 4315 kits) |
| Distribution | Worldwide Distribution-US (nationwide)and the following countries: Afghanistan, Albania, Algeria, Argentina, Aruba, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg, Brazil, British Guyana, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Rep., Ec |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.