Hematology Diluent M-53D used with BC-5390 Hematology recall
Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D diluent is an azide-free…
Why was Hematology Diluent M-53D used with BC-5390 Hematology recalled?
Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzer may cause the system to produce an elevated platelet background count.
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: 2017060105 ¿ 2017041106 ¿ 2017010701 ¿ 2016121401 ¿ 2016112301 ¿ 2016111302
- Product
- Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D diluent is an azide-free…
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Quantity
- 496
- Distribution
- US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .
- Recall date
- April 18, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)