MEDICAL DEVICE RECALL RETURN RESPONSE

Acknowledgement and Receipt Form

Response is Required

PCRopsis Products and Accessories

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:

Question Title

* 2. Enter Date:

MM/DD/YYYY Format

Date

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

Yes

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

Yes

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* 5. If yes, please explain:

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

Yes

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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
Product 1	Product 1 Product/Brand Names, UDI ( if applicable) menu	Product 1 Manufacturer’s Product Number/Catalog Number menu	Product 1 Lot/Serial Number shipped to Customer menu	Product 1 Quantity in Inventory menu	Product 1 Quantity Relabeled menu	Product 1 Quantity Destroyed menu
Product 2	Product 2 Product/Brand Names, UDI ( if applicable) menu	Product 2 Manufacturer’s Product Number/Catalog Number menu	Product 2 Lot/Serial Number shipped to Customer menu	Product 2 Quantity in Inventory menu	Product 2 Quantity Relabeled menu	Product 2 Quantity Destroyed menu
Product 3	Product 3 Product/Brand Names, UDI ( if applicable) menu	Product 3 Manufacturer’s Product Number/Catalog Number menu	Product 3 Lot/Serial Number shipped to Customer menu	Product 3 Quantity in Inventory menu	Product 3 Quantity Relabeled menu	Product 3 Quantity Destroyed menu
Product 4	Product 4 Product/Brand Names, UDI ( if applicable) menu	Product 4 Manufacturer’s Product Number/Catalog Number menu	Product 4 Lot/Serial Number shipped to Customer menu	Product 4 Quantity in Inventory menu

MEDICAL DEVICE RECALL RETURN RESPONSEAcknowledgement and Receipt FormResponse is RequiredPCRopsis Products and Accessories

Question Title

* 1. Company Name:

Question Title

* 2. Enter Date:

Question Title

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

Question Title

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

Question Title

* 5. If yes, please explain:

Question Title

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

Question Title

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

MEDICAL DEVICE RECALL RETURN RESPONSE

Acknowledgement and Receipt Form

Response is Required

PCRopsis Products and Accessories