Pointe Scientific Hitachi AST Reagent R1 : PE plastic recall
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part…
Why was Pointe Scientific Hitachi AST Reagent R1 : PE plastic recalled?
A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert.
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: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101.
- Product
- Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part…
- Recalling firm
- Medtest Holdings, Inc.
- Quantity
- 119.168L across All lots
- Distribution
- US Nationwide Distribution
- Recall date
- May 24, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)