IMMAGE Immunochemistry Systems Rheumatoid Factor recall
IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in…
Why was IMMAGE Immunochemistry Systems Rheumatoid Factor recalled?
The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot variation, and an increase in the percent of patient samples recovering >20 IU/mL using the Lots# M012376 and M101865 of IMMAGE RF reagent. The lots identified for the RF reagent might produce false abnormal results.
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# M012376 and M101865
- Product
- IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 925 units
- Distribution
- Worldwide distribution: USA (nationwide) and country of: Canada.
- Recall date
- October 10, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)