PCRopsis Support: a) recall
PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select…
Why was PCRopsis Support: a) recalled?
Presence of misleading label statements on the product label.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
a) REF 787001, Lot Numbers: 4, Exp. 05/2023; b) REF 787002, Lot Numbers: 4, Exp. 05/2023; 5, Exp. 07/2023; c) REF 787003, Lot Numbers: 5 Exp. 07/2023
- Product
- PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select…
- Recalling firm
- Entopsis , Inc.
- Quantity
- 94 units
- Distribution
- Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
- Recall date
- April 5, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)