Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a recall
Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml…
Why was Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a recalled?
Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.
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?
Catalog numbers: H7545-R1, 12-H7545-162, H7545-1000, HDL600 Lot number: 430402
- Product
- Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml…
- Recalling firm
- Pointe Scientific, Inc.
- Quantity
- H7545-R1, 8.75 L; 12-H7545-162, 4 kits; H7545-1000, 3 kits; HDL600, 6 kits
- Distribution
- Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada.
- Recall date
- September 23, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)