Immulite/immulite 1000 Systems recall
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic…
Why was Immulite/immulite 1000 Systems recalled?
Negative bias results with the IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit was confirmed for two lots (D0119 and D0120). The investigation by Siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/mL.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 1) D01196 - Expiration date 2016-12-31 2) D0120 - Expiration date 2017-03-31
- Product
- IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1379 kits (190 kits in U.S.A and 1189 Kits internationally) in total
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Denmark, Brazil, Croatia and Germany
- Recall date
- February 8, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)