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Entopsis Inc. requests that the product lots shipped/received before February 8th, 2023 be promptly discontinued from use and discarded from inventory as per your non-hazardous waste disposal plan. The labeling of PCRopsis products was revised on February 8th, 2023. Updated statements of intended use and revised instructions for use are available on www.pcropsis.com. If you are currently using or intend to use the PCRopsis product lots affected by this recall please contact us at team@entopsis.net or 1-888-407-5070 (Monday to Friday 9.00 AM to 4.30 PM Eastern Time) to request a replacement. Please acknowledge the removal of affected product lots by filling out the online survey powered by SurveyMonkey. Follow this link provided to see the Recall Letter: https://shop.pcropsis.com/uploads/1/0/1/7/101767230/medical-device-recall-letter_pcropsis_20230327.pdf 

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* 1. Company Name: 

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* 2.  Enter Date:

Date

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* 3. I have read and understand the recall instructions provided in the February 21st letter.

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* 4. Any adverse events associated with the recalled product?

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* 5. If yes, please explain:

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* 6. Please confirm that all affected products have been disposed of.

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* 7. Affected Product Information: Include information that is applicable for the affected product. Please attach additional sheets if necessary. 

  Product/Brand Names, UDI ( if applicable)  Manufacturer’s Product Number/Catalog Number  Lot/Serial Number shipped to Customer  Quantity in Inventory  Quantity Relabeled Quantity Destroyed
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Product 25

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* 8. Return Response Box: (Please provide any additional information, if applicable.)

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